41 jobs found

CSR's Behavioral Health Clinic (BHC) provides high quality, culturally competent, linguistically appropriate, mental health services and support. Our services are community-based, individualized, strengths-based, and outcome oriented. We recognize that achieving well-being requires a holistic approach. The Outpatient Clinical Supervisor will provide weekly supervision to Clinical staff; offer guidance to direct care staff, crisis intervention and emergencies; ensure adherence to professional standards and policies; provide quality assurance through chart review; facilitate peer review and related activities to ensure quality of services; oversee charting and documentation to ensure that clients meet medical necessity criteria for the services; Provide Clinical Supervision for license eligible interns. Responsibilities and Duties: Ensure client confidentiality and privacy, including client records Ensure that clinical records are accurate, current and meet state mandates Ensure that supervisees complete all necessary assessments, treatment plans, and additional documentation in a timely manner and that it is reviewed, approved, and signed as required prior to filing Notify the Program Director or designee of all incidents related to clinical, political, financial, and other liability issues in a timely manner Consider actions to be taken and implement changes to avoid similar incidents in the future and make recommendations for any changes in procedures Ensure that supervisees are following the guidelines to support the implementation of developed treatment plans and they are assisting youth and families in achieving the goals of the plans In collaboration with Quality Assurance, ensure staff compliance with program mandates including charting/documentation and billing Coordinate and/or provide mandated staff training, and other related staff development activities under the direction of the Program Director In collaboration with the Program Director, assure coordination and collaboration among all programs and services; provide support to an integrated case-management approach to client services Assist Behavioral Health Services Program Directors in the development, implementation and evaluation of programming Contribute to the development of client-sensitive policies and procedures that support the delivery of high quality services Other duties/tasks as assigned Qualifications and Skills: Must be Massachusetts CANS certified Must have a valid driver license without restrictions and reliable transportation with valid state minimum insurance coverage Must have a Master's degree in Psychology or related field Must be Independently Licensed to meet programs requirements Must have at least five (5) years post graduate experience providing behavioral health services to youth and families. Experience in n-navigating any of the child/family serving systems and experience in advocating for family members who are involved with behavioral health systems is preferred Use good judgment and maintain effective boundaries when interacting with all members of the staff and the community at large This position requires the individual to work with minimum supervision and the ability to work independently. It also requires the ability to interact with a variety of individuals and the ability to meet deadlines and work under pressure based on the volume of work Guidance is available when necessary and where standards may or may not exist Ability to reason effectively and interpret a variety of instructions- both written and oral Must have excellent writing and communication skills

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science.In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. The Senior Manager, Process Engineering leads a team of engineers who provide technical support to the Devens Cell Therapy Manufacturing Facility. The teams responsibilities include supporting automated (Delta V) manufacturing equipment and systems, manufacturing equipment and locally controlled automation systems, and data aggregation and trending applications. The team also supports process technology transfer, process validation, facility validation, and equipment validation. The Sr. Engineer reports to the Director of Manufacturing Technology. Responsibilities include, but are not limited to, the following: Responsible for the sites Process Validation activities including, but not limited to, Aseptic Process Simulations/ Validations (APS/APV), Process Performance Qualifications (PPQ), and Dynamic Airflow Visualization Studies. Business system owner for Delta V and OSI-PI. Provide support as needed for technology transfer of new or modified processes into the Cell Therapy Facility. Work cross-functionally with the process subject matter experts, Manufacturing Operations, IT / Digital Plant, and Validation on development of recipes and Delta V functionality. Participate in facility risk assessments, author qualification/ validation documents (e.g. procedures, protocols and reports) in accordance with internal and external regulatory expectations. Ensure safe and compliant cGMP operations and maintain permanent inspection readiness and actively support regulatory inspections. Support investigations and change controls as an equipment and automation subject matter expert. Coordinate department validation activities within the production schedule. Perform investigations associated to validation activities (e.g. deviations or OOS during validation studies). Perform data analysis, including the use of statistics, and prepare written reports/summaries from validation studies Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records) ensuring compliance with validated state of the process. Interact with other teams including Process Engineering and Support, QC Microbiology, Manufacturing Operations, and Quality Assurance Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities. Leadership: Create an environment of teamwork, open communication, and a sense of urgency Support the change agent in promoting flexibility, creativity, and accountability Support organizational strategic goals and objectives that are linked to the overall company strategy Drive strong collaboration within the plant and across the network Build trust and effective relationships with peers and stakeholders Deliver business results through timely and quality decision making and advice Foster a culture of compliance and strong environmental, health, and safety performance Promote a mindset of continuous improvement, problem solving, and incident prevention REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: Proficient in cGMPs and multi-national biopharmaceutical/cell therapy regulations Proficient in facility/clean room design, process, equipment, automation, and validation Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities Subject Matter Expert in sterile manufacturing processes, with a strong knowledge of global regulatory requirements (e.g FDA) related to the design and control of the aseptic/environmental aspects of these processes. Experience in sterile manufacturing plant(s) with interaction regarding the EM programs, gowning practices, media fill program, and/or sterilization practices and aseptic technique. Experience with single-use technologies, closed systems, and cold chain/cryogenic technologies Experience working with external parties and/or leading cross-functional teams Excellent verbal/written communication skills and ability to influence at all levels Ability to think strategically and to translate strategy into actions Ability to prioritize and provide clear direction to team members in a highly dynamic environment Experience with Operational Excellence and Lean Manufacturing Education and Experience: Experience with Operational Excellence and Lean Manufacturing is a plus. Experience in cell therapy, biologics, or vaccine manufacturing support, tech transfer, and validation is required. Knowledge of distributed control systems (process automation) is required. Bachelors Degree required (science or engineering is preferred), Advanced Degree is a plus. 8 or more years of manufacturing support or related experience in the biopharmaceutical industry. WORKING CONDITIONS (US Only): Position may require working in Clean-Room manufacturing environment approximately 15% of the time. Remainder of work is performed in an office environment. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives BMSCART Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Overview and Responsibilities: Chippewa Valley Technical College (CVTC) is seeking qualified candidates for an adjunct (part-time) instructor position in our new Agriculture Service Technician program. In addition to serving as the primary instructor in this short-term technical diploma program, this position may assist in the initial development of program curriculum (anticipated to occur prior to June 2021, on a flexible/part-time basis). This position will be based out of our Diesel Education Center.CVTC instructors are dynamic partners for students, employers, and communities to learn, train, and succeed in an associate degree, technical diploma, basic education, continuing education, and/or contract training program. An instructor works with students beyond the classroom to ensure their success, models CVTC core abilities, and demonstrates commitment to excellence in program/course/training content and delivery. An instructor is able to work effectively in a collaborative environment; is willing to innovate and change to meet evolving program and industry needs; and demonstrates competency with use of technology that supports learning and teaching. An instructor maintains a flexible schedule, including availability for evening, weekend, or online assignments, as appropriate.Plan for and instruct courses in the Agriculture Service Technician program. Design and implement relevant and progressive curriculum.Deliver high-quality instruction through the planning and implementation of effective learning strategies and environments.Create performance-based assessments aligned with competencies through formative and summative measures.Promote student success through timely communication, growth-based feedback, and implementation of strategies that meet the needs of diverse learners.Meet professional expectations by maintaining professional currency and contributing to a collaborative culture across the College.Ability to model integrity through self-awareness, personal accountability, ethical behavior, quality standards, and sustainable practices.Ability to think critically by applying problem solving practices, acquiring relevant information, using technology and other resources appropriately, and evaluating alternatives.Ability to communicate effectively by speaking and writing clearly, concisely, and professionally; practicing active listening; reading critically and adapting communication for audience.Ability to value diversity by recognizing personal biases, adapting to culturally diverse situations, and demonstrating a commitment to equity, inclusion, and respectful interactions with persons of diverse ethnic, cultural, social-economic, or educational backgrounds.Please view theAdjunct Instructor Position Description for additional roles and responsibilities of adjunct instructors at CVTC. Qualifications: Associates degree from an accredited college or university in an area preparing a person for the occupational area being taught.Minimum of 2 years (4,000 hours) of occupational experience in a target job for the program or programs being taught, of which at least 1 year (2,000 hours) shall be within 5 years prior to date of hire. One year (2,000 hours) of recent related occupational experience may be waived if the applicant has at least 2 years of postsecondary teaching experience in the appropriate occupational field within 5 years prior to date of hire.Prior teaching or training experience preferred.Qualified per CVTC requirements at time of, and throughout, employment as an instructor. Must also meet and maintain Higher Learning Commission (HLC) requirements, Faculty Quality Assurance System (FQAS) standards, and/or other job specific licensing standards.Must possess and maintain a valid drivers license and acceptable driving record; includes meeting all requirements as indicated by CVTCs insurance carrier.In evaluating candidates for this position, the College may consider a combination of education, training, and experience which provides the necessary knowledge, skills and abilities to perform duties of position.As an equal opportunity/access employer and educator, CVTC is committed to creating and sustaining a diverse and inclusive environment. All qualified candidates are encouraged to apply. Benefits Summary: This position is not eligible for benefits.CVTC does not discriminate on the basis of race, color, national origin, sex, disability, or age in its programs and activities.The following person has been designated to handle inquiries regarding the college's non-discrimination policies: Director of Human Resources, 620 W. Clairemont Avenue, Eau Claire, WI 54701, , WI Relay: 711

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Description • Ensure center is "inspection ready" at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation. Prepare regular reports to center, area and corporate quality management as to the state of quality and systems at the center. • Manage site Quality Control program including but not limited to calibrations management, monitoring of compliance to defined processes e.g. sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis of KPIs, root cause and failure mode impact assessment and change management. • Lead and develop direct reports ensuring they are competently skilled to perform their QA roles. Lead by example; consistently motivate staff through education to high levels of competency that drive success in a dynamic and regulated environment. Upon proper review with center and quality management, recruit, hire, conduct performance reviews and enact corrective actions, up to and including termination. • Participate with management to develop programs and methods to streamline center processes resulting in improved customer/donor service, product yields and financial results while maintaining compliance and quality. • Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Report concerns or deficiencies to area personnel and/or area management immediately. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues of deficiencies. • Lead and function as the key quality representative for site supplier, customer and regulatory audits. Lead center review of findings, coordination of remediation (CAPA), if needed and successful closure of timely audits. Utilize quality tools and applications to facilitate understanding of issues and documentation. • Maintain clean efficient work environment and ensure sufficient operating supplies and availability of forms, as needed. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine audits of internal procedures and documentation, as necessary. Promote safety in all actions. • Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure HR compliance and ensure center management is doing the same. • Comply with all federal, state and local regulatory and company policies and procedures. • Responsible for notification to the ADOQ for any event that negatively affects the safety, quality, identity, purity or potency of the product that results in pausing or disruption of business. If necessary, notification must be elevated to any of the following, Regional Director, Associate Director of QA, Divisional Director or Director of Quality Systems and Assurance. • Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper immune programs at the center if applicable. • Lead investigations and deviations to determine root cause, correction/preventative actions and effectiveness checks. Monitor CAPA's and effectiveness checks to ensure issues are resolved. • Perform other job-related duties as assigned. Education • Bachelor's Degree preferred • Equivalent combination of education and professional work experience required Experience • Minimum 1 year supervisory, leadership experience responsible for overseeing the activities of others, OR • 1 year Quality experience (CSA/CSAb) required OR • Completion of CSL Plasma Leadership Development program Additional Comments • Maintain company Technical Training certification • Knowledge of ever-changing and complex government and industry regulations, and ability to monitor compliance with these regulations • Monitor and manage entire financial responsibility of the center • Proficient in English Working Conditions (physical & mental requirements) • Ability to make decisions which have significant impact on the department's creditability, operations and services • Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Overnight travel required up to 10% of the time • Generally spends 80% of the time standing and walking and 20% of time sitting • Occasionally lift and carry up to 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes working with freezers and various odors • Exposure to human source products and various chemicals including isopropyl, ethyl alcohol, carbon dioxide, iodine, bleach, germicide solution, etc. • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Fast paced environment with frequent interruptions All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB Job Description • Bachelor degree in scientific discipline/life sciences or related discipline • 5+ years' experience related to quality and regulatory/ Plasma industry experience • Demonstrated leadership/supervisory experience • Knowledge of government and industry regulations #CB

ERM seeks a motivated Principal Air Quality & Climate Change Consultant, with significant consulting experience and client relationships, to grow our air quality services business in Louisiana.This is a partner-track opportunity for a Principal-level professional looking to further advance their career with a global environmental leader, and to make a significant impact in successfully implementing ERM's global strategy.ERMs Air Quality & Climate Change service area is a recognized leader in the marketplace. Our technical community pursues and wins highly innovative engagements for the most interesting clients, providing the full breadth of air quality and climate change services. With annual global sales in excess of $50 million, ERMs Air Quality & Climate Change service area is one of the largest among its peers in our industry and is steadily growing at a double-digit pace. In North America alone, ERM has more than 300 dedicated air quality and climate change professionals assisting clients with projects as diverse as developing strategic approaches at the corporate level to upcoming regulatory drivers, to leading complex capital projects through the many hurdles associated with the NSR permitting program.ERM is structured to encourage collaboration and networking among regional offices, providing opportunities to collaborate with ERMs national air quality technical team to share expertise and consulting opportunities. Our many leaders proactively work together to build strategies and campaigns around key business drivers for our clients, with the primary focus of finding and delivering high-profile rewarding projects and building our business, whether it be for GHG reporting regulations, new air dispersion modeling challenges, new MACT and NSPS standards, energy management, or climate change adaptation.As a senior leader on this team, you will be fully accountable for successfully selling and consulting on air quality and climate change projects to build a sustainable business locally, while networking with ERM's global Air Quality & Climate Change technical team to share best practices across the industry. The ideal candidate will be well connected in the regulatory and air permitting community and have established relationships with Oil & Gas, Manufacturing, Technology, or Chemical companies to expand our corporate and facility-level compliance services in the sector of the candidates expertise in Louisiana.RESPONSIBILITIES:Develop and implement strategic market/business plan, provide leadership, and deliver financial results to expand ERM's air quality service area and client base, particularly in the Oil & Gas, Manufacturing, Technology, or Chemical sectors. Serve as a key member of the core technical team to drive double-digit profitable growth of ERMs air quality services business across North America.Serve as a Senior Program Director for strategic air permits and compliance programs for a variety of industrial clients with complex technical/regulatory issues. Work closely with clients and develop strong relationships to understand specific processes and develop a permitting and compliance strategy to help clients maintain maximum operating flexibility. Achieve clients expectations for scope, budget, schedule, and quality.As a leader, be recognized within the Gulf Coast footprint by peers and local agencies for your air quality expertise. Internally, have passion for leading team members and managing a growing and successful business line.As a seller/doer, contribute to expanding ERMs air consulting services annually. Identify and develop new opportunities, prepare effective technical proposals, and take active leadership role in the development of new business with new and existing clients. Develop and expand client relationships that generate repeat business.Capitalize on existing client relationships to expand ERMs profile and market share in the regional Air Quality & Climate Change market and other service-line offerings through a combination of excellence in technical delivery and business development.Mentor junior and mid-level staff in the proper planning and execution of air quality projects, and in directing or conducting independent technical reviews of deliverable work products.Support the general growth and development of ERMs global air quality and climate change services. Collaborate with other ERM global practitioners to execute air quality projects, including participating on teams comprised of Air Quality & Climate Change professionals from multiple offices around the global organization.Advanced or subject matter expertise in air permitting; other compliance-related areas a plus (e.g., air dispersion modeling, storm water, SPCC, RMP/PSM, CEQA permitting, multi-media auditing, etc.).Familiarity with and stack testing and ambient air measurement a plus.Develop a working understanding of ERMs other consulting service areas and actively support cross-selling other services to existing clients.REQUIREMENTS:Experience and confidence to lead and grow business in a dynamic market environment.Minimum of BS in engineering (chemical, mechanical, environmental) or related discipline;Certification in field; P.E., CSP, CHMM, or similar registration desired.15+ years of solid air quality consulting experience, with a high degree of technical competence in Title V, PSD, NSR, BACT, and MACT.In-depth understanding of the Oil & Gas, Manufacturing, Technology, or Chemical industry in California and the companies operating in this sector, including existing relationships that can be leveraged into new businessConsistent "seller/doer" track record, including successfully winning large and strategic projects.An established reputation in the local marketplace and recognized technical expertise in one of ERMs existing service offerings, which include but are not limited to air quality and climate change, EHS compliance assurance, process safety, sustainability, and environmental permittingDemonstrated leadership ability to build, coach, and mentor collaborative teams.Excellent communication (written/verbal), strategic thinking, negotiation, presentation, and people skills.Positive outlook, collaborative, and driven by the success of ERM as a global company.Who We Are:As the worlds leading sustainability consulting firm, ERM is uniquely positioned to contribute to the environment and society through the expertise and energy of our employees worldwide. Sustainability is what we do, and is at the heart of both our service offerings and how we operate our business. ERM and our partners are driven by a dynamic vision: By 2021 we will be the clear leader in our chosen markets, we will double in value and we will deliver on our promises to our clients, our people and our investors. For our people, our vision means attracting, inspiring, developing and rewarding our people to work with the best clients and on the biggest challenges, thus creating valuable careers. We achieve our vision in a sustainable manner by maintaining and living our ERM values that include Accountability, Caring for our People, Client Focus, Collaboration, Empowerment, and Transparency. Please submit your resume and brief cover letter.ERM does not accept recruiting agency resumes. Please do not forward resumes to our jobs alias, ERM employees or any other company location. ERM is not responsible for any fees related to unsolicited resumes.ERM is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.Thank you for your interest in ERM!

The Role At Last Mile Health (LMH), we dig data. Are you passionate about global health and have prior experience with digital data collection systems and managing technologing projects? If so, you may be the next Digital Health Coordinator on our Health Systems Strengthening Team! Informed by over a decade of working alongside the Government of Liberia, Last Mile Health is partnering with countries to design and build community-based primary health systems. Since 2015, LMH has launched or is planning digital health interventions across Ethiopia, Liberia, Malawi, Sierra Leone, and Uganda. The Digital Health Coordinator sits on the Digital Health (DH) practice of the Health Systems Strengthening Team (HSS). The HSS acts as a hub to provide technical support to in-country digital health programs, teams, and governments. The Digital Health Coordinator will support partner coordination, DH Strategy and learning plans, and support system building in digital health interventions across LMH's geographies.  This position is open to candidates located in Malawi, Liberia, Uganda, Ethiopia, and on the Eastern seaboard of the United States (preference to New York City and Boston). Candidates must have the ability to work in one of the countries listed above. Please note that our US offices are currently closed due to COVID 19 and all US based staff are working remotely. What You'll Do Support landscape assessments of in-country digital health by connecting team members to relevant briefs, documents, and global best practices Support country teams to understand their digital health hardware logistics needs Improve Global Digital Health's cross-team coordination mechanisms, particularly between LMH's Monitoring, Evaluation, Research, & Learning (MERL) and Education Teams Work with the Software Development Manager to generate software training materials for team members and governments to administer global software products Generate materials to train the government on how to create new courses in Moodle, how to administrate learners, and conduct data collection and analysis Support external global vendor engagement on project planning, contracting, and invoice processing Contribute to global technical working groups (such as Community Health Toolkit, group incorporating performance management elements into OpenSRP, and the Health Data Collaborative DC group) Debrief HSS and in-country teams on the latest business developments and software improvements to relevant digital health platforms and vendors Support the DH Director to facilitate LMH's DH Advisory Committee and create documentation that helps LMH staff members understand LMH's global DH strategy Administer and organize DH reports and technical documentation in the Global DH Drive ensuring in-country teams have access to relevant documents and support organize their information and versioning Work with DH Director of Strategy, MERL, and in-country teams to develop and actualize MERL plans for all DH activities Attend digital health conferences & virtual workshops and manage LMH's Digital Health Literature catalog Conduct internal/external feedback surveys to assess challenges/success of LMH's digital health work What You'll Bring A Bachelor's degree in a relevant field, such as Computer Science, International Development, Public Health Experience with digital projects and digital data collection systems, ideally in healthcare Several years of experience in project management, including project coordination, and budget management Prior exposure to conducting agile management, requirements gathering, quality assurance testing, and user-centered design Demonstrated experience in public health/designing and deploying public health information systems. Ability to manage a considerable volume of detail and of accurately summarizing project status to executives and stakeholders Experience in improving project management tools and techniques to contribute to the management and optimization of multiple project teams. Excellent leadership, communication (written, verbal, and presentation), and interpersonal skills Experience managing and tracking project budgets, forecasts, and schedules to achieve target scope, schedule, and cost Ability to maintain relationships by engaging stakeholders to establish credibility, solve problems, build consensus and achieve objectives. You'll Impress Us If You have a certification in Program or Project Management You have working experience with Agile software development management, familiarity with popular digital software such as ODK, CommCare, OpenSRP, and DHIS2. You have prior experience with government and non-profit projects, demonstrating experience in large-scale technology initiatives in low resource environments Compensation and Benefits Information As LMH strives to increase transparency into our compensation principles we are highlighting below more details around our compensation policy and benefits associated with this position. In line with our compensation principles, this position will pay at the 50th to 60th percentile of the market to which you are employed. We look forward to answering any questions you may have during the hiring process. Principles guiding our compensation policy: Data Driven: We benchmark salaries against large datasets containing compensation data from organizations with whom we compete for talent. We benchmark salaries for specific roles and specific candidate experience. Competitive: Candidates should be paid the most competitive salaries possible for their position given budgetary constraints. We aim to pay above market, typically between the 50th-60th percentile of the market. Transparent: Compensation policies should be transparent and easily understood. We want all candidates to understand how we set salaries and to know we aim to pay competitively. Equitable: Compensation should be implemented consistently across candidates of different identities, teams and geographies, while keeping into account the different talent markets and economies we operate in. Responsible: LMH needs to operate in a sustainable way and practice good stewardship of our resources. About Last Mile Health Last Mile Health (LMH) saves lives in the world's most remote communities by partnering with governments to bring critical primary care services to the doorsteps of people living in the last mile. LMH is a registered 501(c)3 non-profit organization with offices in Liberia, Malawi, Boston, and New York. For more information, visit . We are an equal opportunity employer and value diversity at LMH. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Description • Ensure center is "inspection ready" at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation. Prepare regular reports to center, area and corporate quality management as to the state of quality and systems at the center. • Manage site Quality Control program including but not limited to calibrations management, monitoring of compliance to defined processes e.g. sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis of KPIs, root cause and failure mode impact assessment and change management. • Lead and develop direct reports ensuring they are competently skilled to perform their QA roles. Lead by example; consistently motivate staff through education to high levels of competency that drive success in a dynamic and regulated environment. Upon proper review with center and quality management, recruit, hire, conduct performance reviews and enact corrective actions, up to and including termination. • Participate with management to develop programs and methods to streamline center processes resulting in improved customer/donor service, product yields and financial results while maintaining compliance and quality. • Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Report concerns or deficiencies to area personnel and/or area management immediately. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues of deficiencies. • Lead and function as the key quality representative for site supplier, customer and regulatory audits. Lead center review of findings, coordination of remediation (CAPA), if needed and successful closure of timely audits. Utilize quality tools and applications to facilitate understanding of issues and documentation. • Maintain clean efficient work environment and ensure sufficient operating supplies and availability of forms, as needed. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine audits of internal procedures and documentation, as necessary. Promote safety in all actions. • Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure HR compliance and ensure center management is doing the same. • Comply with all federal, state and local regulatory and company policies and procedures. • Responsible for notification to the ADOQ for any event that negatively affects the safety, quality, identity, purity or potency of the product that results in pausing or disruption of business. If necessary, notification must be elevated to any of the following, Regional Director, Associate Director of QA, Divisional Director or Director of Quality Systems and Assurance. • Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper immune programs at the center if applicable. • Lead investigations and deviations to determine root cause, correction/preventative actions and effectiveness checks. Monitor CAPA's and effectiveness checks to ensure issues are resolved. • Perform other job-related duties as assigned. Education • Bachelor's Degree preferred • Equivalent combination of education and professional work experience required Experience • Minimum 1 year supervisory, leadership experience responsible for overseeing the activities of others, OR • 1 year Quality experience (CSA/CSAb) required OR • Completion of CSL Plasma Leadership Development program Additional Comments • Maintain company Technical Training certification • Knowledge of ever-changing and complex government and industry regulations, and ability to monitor compliance with these regulations • Monitor and manage entire financial responsibility of the center • Proficient in English Working Conditions (physical & mental requirements) • Ability to make decisions which have significant impact on the department's creditability, operations and services • Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Overnight travel required up to 10% of the time • Generally spends 80% of the time standing and walking and 20% of time sitting • Occasionally lift and carry up to 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes working with freezers and various odors • Exposure to human source products and various chemicals including isopropyl, ethyl alcohol, carbon dioxide, iodine, bleach, germicide solution, etc. • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Fast paced environment with frequent interruptions All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB Job Description • Bachelor degree in scientific discipline/life sciences or related discipline • 5+ years' experience related to quality and regulatory/ Plasma industry experience • Demonstrated leadership/supervisoryexperience • Knowledge of government and industry regulations #CB

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Description • Ensure center is "inspection ready" at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation. Prepare regular reports to center, area and corporate quality management as to the state of quality and systems at the center. • Manage site Quality Control program including but not limited to calibrations management, monitoring of compliance to defined processes e.g. sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis of KPIs, root cause and failure mode impact assessment and change management. • Lead and develop direct reports ensuring they are competently skilled to perform their QA roles. Lead by example; consistently motivate staff through education to high levels of competency that drive success in a dynamic and regulated environment. Upon proper review with center and quality management, recruit, hire, conduct performance reviews and enact corrective actions, up to and including termination. • Participate with management to develop programs and methods to streamline center processes resulting in improved customer/donor service, product yields and financial results while maintaining compliance and quality. • Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Report concerns or deficiencies to area personnel and/or area management immediately. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues of deficiencies. • Lead and function as the key quality representative for site supplier, customer and regulatory audits. Lead center review of findings, coordination of remediation (CAPA), if needed and successful closure of timely audits. Utilize quality tools and applications to facilitate understanding of issues and documentation. • Maintain clean efficient work environment and ensure sufficient operating supplies and availability of forms, as needed. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine audits of internal procedures and documentation, as necessary. Promote safety in all actions. • Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure HR compliance and ensure center management is doing the same. • Comply with all federal, state and local regulatory and company policies and procedures. • Responsible for notification to the ADOQ for any event that negatively affects the safety, quality, identity, purity or potency of the product that results in pausing or disruption of business. If necessary, notification must be elevated to any of the following, Regional Director, Associate Director of QA, Divisional Director or Director of Quality Systems and Assurance. • Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper immune programs at the center if applicable. • Lead investigations and deviations to determine root cause, correction/preventative actions and effectiveness checks. Monitor CAPA's and effectiveness checks to ensure issues are resolved. • Perform other job-related duties as assigned. Education • Bachelor's Degree preferred • Equivalent combination of education and professional work experience required Experience • Minimum 1 year supervisory, leadership experience responsible for overseeing the activities of others, OR • 1 year Quality experience (CSA/CSAb) required OR • Completion of CSL Plasma Leadership Development program Additional Comments • Maintain company Technical Training certification • Knowledge of ever-changing and complex government and industry regulations, and ability to monitor compliance with these regulations • Monitor and manage entire financial responsibility of the center • Proficient in English Working Conditions (physical & mental requirements) • Ability to make decisions which have significant impact on the department's creditability, operations and services • Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Overnight travel required up to 10% of the time • Generally spends 80% of the time standing and walking and 20% of time sitting • Occasionally lift and carry up to 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes working with freezers and various odors • Exposure to human source products and various chemicals including isopropyl, ethyl alcohol, carbon dioxide, iodine, bleach, germicide solution, etc. • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Fast paced environment with frequent interruptions All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB Job Description • Bachelor degree in scientific discipline/life sciences or related discipline • 5+ years' experience related to quality and regulatory/ Plasma industry experience • Demonstrated leadership/supervisoryexperience • Knowledge of government and industry regulations CSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL's 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. #CB

Description Manager Research Regulatory Services - Research Administration - AdventHealth Orlando Location Address: 800 N. Magnolia Ave., Orlando, FL 32801 Top Reasons to work at AdventHealth Orlando Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando serves as the major tertiary facility for much of the Southeast, the Caribbean and South America AdventHealth Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year Work Hours/Shift: Full Time, Days You Will Be Responsible For: The Manager - Research Regulatory & IND is knowledgeable of all Federal regulations, International and accreditation standards, and AdventHealth Research Institute (AHRI) and Institutional Review Board (IRB) policies and procedures governing biomedical and clinical research. The Research Regulatory Manager will manage the Research Regulatory team who handles all of the IRB and regulatory submissions and processes for all of AdventHealth Research Institute (AHRI) research activities. The Research Regulatory Manager will guide the Research Regulatory team working towards the standardization and streamlining of research regulatory start-up, submission, maintenance, and close-out work flows and processes with a goal of efficiency and compliance. Acts as a liaison and facilitate regular and effective communication between the regulatory staff, the AHRI Orlando IRB, external central IRBs, the Office of Sponsored Programs (OSP), participating cooperative groups, consortiums, sub-contract sties, Investigators, Research Nurses, Data Managers, and pharmaceutical monitors. Actively contribute to providing outstanding customer service, accepts responsibility for maintaining relationships that are equally respectful to all. Qualifications What You Will Need: LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED: Certification (upon hire or within first year) through any professional research organization such as the Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators International (SRA), or Public Responsibility in Medicine & Research (PRIM&R). EDUCATION AND EXPERIENCE REQUIRED: Associate degree in biological sciences or healthcare related field. At least three years' experience in research regulatory field, working with U.S. Federal research regulations, ICH GCP guidelines, and IRBs in a clinical research setting. Demonstrated leadership such as participating in interdepartmental committees or leading a group/team or special projects successfully. EDUCATION AND EXPERIENCE PREFERRED: Bachelor's degree in biological sciences, healthcare, administration, or research related field. At least five years of experience in research regulatory field One to three years management experience. Public speaking/training experience. SUPERVISORY RESPONSIBILITIES Supervision of the Research Regulatory Services Team. research staff and participating in inter-departmental discussions relevant to clinical research. KNOWLEDGE AND SKILLS REQUIRED: In-depth knowledge of U.S. Federal research regulations and governing agencies and bodies, including, but not limited to, The Common Rule, Food and Drug Administration (FDA) regulations for research with investigational drugs, devices, and biologics, International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP), Association for the Accreditation of Human Research Protection Programs (AAHRPP), as well as applicable State laws. Expertise in the submission process of research regulatory documents to an IRB and to Federal agencies (i.e., FDA) as required, including experience working with Central IRBs. Motivated, proactive and able to function with minimal direction, prioritizing tasks and workflow for the Research Regulatory team. Leadership skills demonstrated by the ability to lead a group to complete an assigned task or goal. Strong multi-tasking skills with the ability to adjust priorities as needed. Ability to be flexible in a fast-paced environment and respond to the changing needs and rules of clinical research regulatory requirements, standards, and guidelines. Strong written and verbal communication skills. Excellent organizational and electronic filing skills. Proficient in Microsoft Office applications and internet skills. KNOWLEDGE AND SKILLS PREFERRED: Knowledge of AHRI Orlando IRB policies and procedures. Experience working with cancer cooperative groups. Experience with National Institutes of Health (NIH) and National Cancer Institute (NCI) requirements, and/or Oncology clinical research. Experience with Investigator Initiated studies. Experience with Emergency and Treatment Investigational New Drug (IND) applications to the FDA. Proficient in Florence eRegulatory application. Expertise in IRBNet electronic IRB application. Knowledge of medical terminology. Job Summary: Performs a variety of supervisory duties related to the management, performance, evaluations, development and workflow of the Research Regulatory team. Manages the work assignments, priorities and productivity of the research regulatory staff. Manage Florence eRegulatory application including role assignments, access, and workflows. Facilitate the review of research regulatory documents for sponsor monitors, and external auditors working with the site department. Develop and maintain standardized processes for regulatory workflows across all regulatory staff. Coordinate regulatory processes for AHRI led multi-site research. Ensure effective communication between AHRI coordinating site and all participating study teams for all multi-site studies and Investigator Initiated Studies (IIS) with more than one location or site. Provides and/or ensures regulatory support for AHRI investigators conducting AHRI sponsored FDA regulated research, (Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications and maintenance. Create and facilitate streamlined process for emergency IND submissions (FDA and IRB processes). Oversees orientation and training of new research regulatory staff. Provides study activation support for AHRI IIS, assisting with site initiation activities. Provides quality assurance and quality control oversight of the regulatory process ensuring each project is audit ready at all times. Works closely with the ORI Director and Research Compliance Manager to ensure proper research compliance is maintained and all documents are submitted to the IRB in accordance with State, and Federal regulations. Assists ORI Director and Research Compliance Manager with the development of AHRI Standard Operating Procedures (SOPs) Contributes to providing efficient customer service by maintaining open communication with all research staff and participating in inter-departmental discussions relevant to clinical research. This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.

Imperial Healthcare & Wellness Center - POSITION DESCRIPTION: Under the direction of the Administrator, the Interim Director of Nursing Services is responsible for the administration and management of Nursing Services to residents in accordance with orders of the physicians and total needs of the residents. Responsible for 24-hour supervision of Nursing Services. QUALIFICATIONS • A graduate from an accredited school of professional nursing. • Current licensure as a Registered Nurse in the state in which practicing. • Experienced or trained in nursing service administration, rehabilitation, psychiatric or geriatric nursing. • One or more years of demonstrated ability in nursing administration and/or supervision in a health facility. • Demonstrates knowledge of and ability to apply basic principles of nursing care and teaching. • Demonstrates leadership ability and capability to work effectively with all levels of personnel. • Maintains an interest and knowledge of current trends and new developments in nursing and health administration. • Demonstrates interest and ability to work effectively with the public. • A desire to work with geriatric and disabled persons. • Ability to generate enthusiasm and cooperation from others. • Ability to develop and maintain good interpersonal relationships. • Possession of good emotional and physical health. • Ability to communicate effectively in English through both speech and writing. • A genuine interest in and respect for people and a desire to be of service to them. • Ability to accept and work with persons with different social and cultural traits. • Ability to work in a long-term care environment. GENERAL DUTIES AND RESPONSIBILITIES: GENERAL • Assumes ultimate responsibility for coordinating plans for the total care of each resident which comply with physician's orders, governmental regulations and facility resident care policies. • Develops, maintains and upgrades nursing service objectives, standards for nursing practice, nursing procedure manuals and written job descriptions for each level of nursing personnel. • Participates in the recruitment, selection, hiring, orientation, training and dismissal of nursing personnel. • Assists in controlling nursing service hours and supply costs, including recommendation for the number and type of nursing personnel to be employed and nursing service equipment and supply needs. • Participates in admission and discharge planning for residents. • Maintains contact with physicians as necessary according to resident needs, facility policies and governmental regulations. • Evaluates information to be shared with outside nursing personnel and allied services for continuity of resident care. • Assess community resources that may be utilized to improve resident care. • Maintains good interpersonal relationships with residents and their families, nursing personnel, allied professional services and the community. • Periodically visits residents to ensure maximum care and to ascertain need to additional or modified services. • Participates in professional organization activities, identifies and meets educations need of staff through meeting and in-service classes. • Attends and participates in all required meetings, conferences and policy making committees in the facility. • Promotes a safe environment within the facility, which includes fire and accident prevention, maintenance of sanitary conditions and assurance that all nursing personnel understand their roles in the event of a disaster or other disruption of services. • Assures that an adequate orientation and in-service training program is provided for all nursing personnel. • Confers daily with the Administrator regarding current status of nursing services and submits written reports as requested. SUPERVISION • Assigns duties and delegates responsibilities to nursing personnel according to their abilities. • Evaluates performance of nursing personnel reporting to her/him and maintains evaluation records. • Coordinates nursing service with other resident care services provided; such as physician, dietary, occupational, physical and speech therapies, resident activities, social services, medical records and business office. • Assures that a resident Plan of Care is established for each resident and that the plan is reviewed and modified as needed. • Encourages staff development and professional growth. • Assures adequate 24-hour nursing coverage in the facility each day. • Designates a responsible professional nurse to be in charge of the nursing service during the absence of the Nursing Director. • Provide close supervision and direction to the Charge Nurses to continually improve the nursing care of residents. • Reviews and corrects findings and deficiencies of Pharmacy Consultant, Department of Health Services, Dietary Consultant, Medical Records Consultant, Quality Assurance Team and prevent reoccurrence by implementation of recommendations and follow through. • Maintains quality assurance in facility by frequent nursing rounds and continuous assessment of resident conditions from admission through discharge. • Assumes responsibility for investigation of alleged abuse or unusual occurrence as outlined within our established policies and procedures. CONSUMER SERVICE • Presents professional image to consumers through dress, behavior and speech. • Adheres to Company standards for resolving consumer concerns. • Ensures that all resident rights are protected.

Behavioral Sciences Analyst Job Title: Behavioral Sciences Analyst Location: Omaha, NE- In office, not remote About TPG: TPG is a purpose-driven innovation organization offering solutions in business advisory, customer experience, forward leaning technology, and analytics. TPG partners with companies to equip, engage, and empower them to act strategically to improve customer experience. TPG is currently the leader of independent, third party quality assurance for customer experience and interaction management to Fortune 500 businesses. TPG delivers predictive intelligence, analytical reporting, and hands on assessments by applying data sets to our proprietary, AI based assessment and reporting platform. By developing individualized quality performance goals alongside our clients, we deliver impactful results. Job Description: As a Behavioral Science Analyst in TPG's Behavioral Sciences Team you will be responsible for the quality control of data collection, observation, and evaluation of interactions between clients and customers, and the documentation of these interactions. You will be expected to analyze interactions between clients and customers by listening and observing voice, email, and interactive chat mediums, accurately evaluating and scoring these interactions and providing accurate and scalable product deliverables. Behavioral Science provide valuable insight by contributing strategic inputs to client deliverables and by supporting work stream requirements. Behavioral Science Analysts are expected to accurately evaluate interactions and provide accurate analysis of data outputs based on information provided via the AI Platform and Compendium. Behavioral Science Analysts must demonstrate a willingness to learn and develop a clear understanding of TPG's Compendium applications, evaluation processes and supporting the development of product deliverables. It is important for Behavioral Science Analysts to demonstrate an eagerness and willingness to learn and understand Compendium Applications and all related product deliverables. It is critical for Behavioral Science Analysts to appreciate and understand how Compendium and all associated applications are deeply rooted across TPG Product Offerings. You will be responsible for working with and supporting team members on the creation of products utilizing the various Compendium Applications. Data integrity and accuracy is crucial to the successful delivery of these client products which directly influence and drive client ROI. Team Contribution Understands TPG's CX Platform and how their role integrates and supports all facets of our business Leverages Ideal Conversation Platform, On-Demand reporting, and data health reports to diagnose and solve for any data discrepancies in their delivery Understands the story of the data and how they contribute to our ability to deliver both our Human Diagnostic and Dynamic AI Completes all of their analysis in a timely manner with limited oversight Be receptive to coaching and professional Support Behavioral Science Team on work stream and client deliverables Meet both individual and team revenue and sampling goals each month Ability to self-diagnose work to ensure accurate and consistent scoring Participate in all scheduled development activities including calibrations, feedback sessions, training, special projects, etc. Actively utilize TPG's software suite to create a proficiency in the products that we market Understand TPG's product offering and how to apply them Responsible for the accurate collection of information, analyzing data and the evaluation of that data TPG Business Relationships Ensures the health and accuracy of their analysis by fully understanding their client's business and Evaluate Compendiums Provide client related support to contribute to the strategy for your client Understand and remain current on knowledge of client's programs and goals Utilize voice, chat and email media, observe and accurately evaluate interactions between clients and customers Responsible for observing, gathering, and evaluating customer and client interactions via various mediums Interpersonal and Communication Skillset Create professional and positive lasting connections with colleagues, clients, and partners alike, who interact with TPG Demonstrate strong interpersonal and communication skills Ability to craft and deliver clear written communication, with great attention to detail Critical thinking skills and intellectual curiosity Personal accountability Ability to work independently, establish priorities and meet deadlines A strong work ethic that will enable the delivery of revenue each month Proficiency in or knowledge of using a variety of computer software applications, especially Microsoft Office Suite Ability to handle sensitive and confidential situations and documentation Presentation and verbal communication skills Living TPG's Mission Fulfill TPG's Mission Effectively deliver our Mission, both internally and externally Participate in professional growth opportunities, training sessions and performance evaluations Living TPG's Core Values Demonstrate TPG's Core Values Live out TPG values and hold teams accountable to do the same TPG Goals Engage in short and long-term business goals by providing insight and innovative solutions to leadership Develop plans and ensure delivery of our systematic processes Qualifications 2+ years work experience/education High school Diploma or GED Additional Qualifications Preferred Associate degree, bachelor's degree or technical school coursework preferred Experience in Telecommunications, Healthcare, Financial and/or International markets Multilingual Benefits Competitive Salary Tremendous Opportunities for Upward Mobility Positive People Culture & Work Team Environment Medical Dental Life Disability FSA 401(k) Supervision The Behavior Science Analyst has no direct reports Physical Requirements Sitting and standing for long periods may be necessary Move around the office, use of hands for typing Ability to hear and see, read from computer monitor Ability to travel if required (limited) TPG EEO Statement, 2020 : TPG is a company that has been built on diversity and disruptive strategy. At TPG we support, accept, and embrace differences. 24 years of success has been a direct result of our diverse people-culture model. At TPG we believe that individuals should be hired and promoted based on aligning qualifications, merit, experience, and professional acumen. TPG does not discriminate against applicants or existing employees based upon age, color, creed, disability, genetic information, gender, gender identity, marital status, national origin, pregnancy or breast-feeding, veteran status and/or any other basis protected by law. TPG is a company that believes in fostering creativity, innovation, and success by offering a safe, non-threatening environment in which our employees, products and clients can thrive. It is TPG's policy to comply with all applicable national, state, and local laws pertaining to non-discrimination and equal opportunity regulations. TPG's Founder & CEO, Executive Staff, our Board of Directors and Advisors strongly advocate, support, and stand behind this EEO Policy and our Affirmative Action Obligations. As leaders in our market space, we adhere to these standards, not only because it is enforceable under the law, but because it is inherent to our core values. Our leadership team believes in building a strong corporate enterprise lead by a strong moral compass and leaders that follow it. If you join our team, we expect you to do the same.

Northwest Healthcare Center - Purpose/belief statement:The Social Work Director will work with residents in the nursing home by identifying their psychosocial, mental and emotional needs along with providing, developing, and/or aiding in the access of services to meet those needs. Services will be provided in accordance with the National Association of Social Workers (NASW) Code of Ethics along with strict adherence to government regulations. The nursing home social work director is responsible for fostering a climate, policies and routines that enable residents to maximize their individuality, independence and dignity. This climate shall provide residents with the highest practical level of physical, mental and psychosocial well-being and quality of life.Job duties & responsibilitiesPERFORM ALL DUTIES INVOLVED IN RESIDENT ADVOCACYThe position of Social Service Director functions as a facility leader and provides planning, assessment, coordination and implementation of services to enhance each residents social and psychosocial well-being and assure that care standards are met and the highest degree of quality resident care is provided at all times. The position is that of a working Director with a case load as well as supervisory responsibility and must function as both a team member, team leader, and supervisor to ensure that work is accomplished and quality care is delivered, supporting team members and leading the way in celebrating team successes. While focusing on delivering quality care, the position must also manage the resources within their control and assist others in managing resources.ResponsibilitiesCompletes all required UDAs and assessments timelyCompletes all advance directives as neededCompletes all required care plans timelyCompletes assigned MDS sections timelyCompletes initial care plan and care planning meetings in required time periodInitiates and maintains PASRR records and completes all reviews in required time period.Accurately maintains PASRR tracking to assure timely completion of screenings and resident reviews.Completes LOC as necessary and timelyInitiates discharge planning upon admission and coordinates a safe transition back to communityPresents all advance beneficiary notices timelyAssures room change notifications are administered, signed and uploaded into medical recordDevelops and maintains a good working rapport with the interdisciplinary team to coordinate all aspects of care and to assure their participation and support of all programs/services to benefit the residents psychosocial well-being.Participates in pharmacy and therapeutics meetingParticipates in all initial/quarterly/annual care conferences and attends any other meetings Reports all grievances and complaints and make necessary oral/written reports to the Administrator/designee.Participates in orienting new staff to the facility Maintains confidentiality of all resident/family information at all times.Maintains contact with residents families inviting them to care conferences, encouraging them to remain involved in the care and life of the resident and informing them of any change in the residents psychosocial well-being as needed.Completes short term and long term surveys with residents/representativePlaces initial follow-up call to residents discharged to homeHires, trains, supervises and reviews all social service employeesRESPONSIBLE FOR THE PERFORMANCE OF ALL SOCIAL AND PSYCHOSOCIAL FUNCTIONSAdvocacyWork with the interdisciplinary team and administration to promote and protect resident rights and the psychological well-being of each resident. Prevent and address resident abuse as mandated by law and professional licensure.Identify community changes and opportunities such as legislation, regulations and programs that affect nursing home residents.Work with residents, families, significant others and staff to provide support, information and organization for taking a proactive role and function as an advocate to improve the quality of life/care for individual residents and those who live and work within the nursing home and the community at large.MAINTAIN PROPER DOCUMENTATION AND PERFORM GENERAL DUTIESPrepares, evaluates and charts social service documentation on each resident according to State and Federal regulations, to include MDSs, and Raps.Documents initial social assessment, social history, discharge plan, progress notes and other assessments per company policy, federal and state regulations.Maintains clean office area, organized and presentable at all times in order for you to be able to meet with resident families and other service providersMaintain a professional appearance, manner and approach while on duty.ATTEND AND PARTICIPATE IN SCHEDULED TRAINING, EDUCATION CLASSES, AND ORIENTATION PROGRAMS TO MAINTAIN AND ENHANCE QUALITY OF CARE and ADHERE TO STATE AND LICENSING REGULATIONS.Mandatory attendance at all scheduled supervision as required by state regulations for social work compliance in long term care.Attend all required in-service and training programs required within your department.Attend any mandatory meeting as required by your center.PERFORM OTHER RELATED ACTIVITIES AS ASSIGNED OR REQUESTED.MAINTAIN AND WORK WITHIN ESTABLISHED DEPARTMENTAL, CENTER, AND HOME OFFICE POLICIES AND PROCEDURES, OBJECTIVES, QUALITY IMPROVEMENT PROGRAM, AND SAFETY, ENVIRONMENTAL AND INFECTION CONTROL STANDARDS.Qualifications & Experience requirementsRequired 4 year college degree in social work or related field as per federal and state requirements, bachelor or masters degree in social work preferred.Academic credentials as mandated by federal and state licensure requirementsLicensure: As per federal and state requirements and preferred for all social work graduates.3-5 years of prior work in a healthcare setting skilled nursing and/or long term care setting preferred.3-5 years of prior supervisory experience and management training preferredPrior experience preferably with related software applications.Knowledge/Skills/AbilitiesAdministrativeReview facility policies and procedures as part of the facilitys interdisciplinary team to assure compliance with state and federal regulations.Participate in reviewing and setting policies concerning resident care and quality of life.Participate in developing facility and company social work policies.Develop, maintain and utilize a listing of current community resources that are useful to in discharge planning and for residents and families.Participate in quality assurance interdisciplinary team meetings.Understand and meet all government requirements for social service documentationDocument progress in meeting the psychosocial needs of residents.Must have strong communication skills.Must have the ability to make independent decisions when circumstances warrant such action.Must be willing to seek out new methods and principles and be willing to incorporate them into existing practices.Basic computer literacy and skills.Clinical(Level of clinical intervention is dependent on education and licensing of the individual)Complete a social history and psychosocial assessment for each resident that identifies social, emotional, and psychological needs.Participate in the development of a written, interdisciplinary plan of care for each resident that identifies the psychosocial needs/issues of the resident, the goals to be accomplished for those needs/issues, and the appropriate social worker interventions.Ensure or provide therapeutic interventions to assist residents in coping with their transition and adjustment to a long-term care facility, including their social, emotional, and psychological needs.Ensure or provide support and education to residents/family members/significant others to assist in their understanding of placement and facility issues in addition to referring them to the appropriate social service agencies when the facility does not provide the needed services.Provide or ensure groups for residents/family members/significant others as appropriate to their needs.Provide or ensure clinical interventions to address catastrophic events that occur during the residents stay in the facility.Coordinate the resident discharge planning process and make referrals for appropriate home care services prior to the residents return to the community.Work environmentMay work beyond normal working hours, on weekends and holidays, when necessary.Is subject to frequent interruptions.Field based work required. Occasional overnight travel will be required as times with field based assignments.Physical effort/demands (With or Without the Aid of Mechanical Devices)Ability to move (sit, stand, bend, lift) intermittently throughout the workday.Ability to lift, push, pull, and move a minimum of 50 pounds.Mental effort/demands (With or Without the Aid of Mechanical Devices)Ability to function independently and have flexibility, personal integrity, and ability to work effectively with staff and support agencies.In good health and demonstrating emotional stability.Ability to cope with the mental and emotional stresses of the position.Communication (With or Without the Aid of Mechanical Devices)Must be able to read, write and speak the English language in an understandable manner.Sensory requirements (With or Without the Aid of Mechanical Devices)Ability to see and hear or use prosthetics that will enable these senses to function adequately to assure that the requirements of this position can be fully met.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Description • Ensure center is "inspection ready" at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation. Prepare regular reports to center, area and corporate quality management as to the state of quality and systems at the center. • Manage site Quality Control program including but not limited to calibrations management, monitoring of compliance to defined processes e.g. sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis of KPIs, root cause and failure mode impact assessment and change management. • Lead and develop direct reports ensuring they are competently skilled to perform their QA roles. Lead by example; consistently motivate staff through education to high levels of competency that drive success in a dynamic and regulated environment. Upon proper review with center and quality management, recruit, hire, conduct performance reviews and enact corrective actions, up to and including termination. • Participate with management to develop programs and methods to streamline center processes resulting in improved customer/donor service, product yields and financial results while maintaining compliance and quality. • Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Report concerns or deficiencies to area personnel and/or area management immediately. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues of deficiencies. • Lead and function as the key quality representative for site supplier, customer and regulatory audits. Lead center review of findings, coordination of remediation (CAPA), if needed and successful closure of timely audits. Utilize quality tools and applications to facilitate understanding of issues and documentation. • Maintain clean efficient work environment and ensure sufficient operating supplies and availability of forms, as needed. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine audits of internal procedures and documentation, as necessary. Promote safety in all actions. • Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure HR compliance and ensure center management is doing the same. • Comply with all federal, state and local regulatory and company policies and procedures. • Responsible for notification to the ADOQ for any event that negatively affects the safety, quality, identity, purity or potency of the product that results in pausing or disruption of business. If necessary, notification must be elevated to any of the following, Regional Director, Associate Director of QA, Divisional Director or Director of Quality Systems and Assurance. • Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper immune programs at the center if applicable. • Lead investigations and deviations to determine root cause, correction/preventative actions and effectiveness checks. Monitor CAPA's and effectiveness checks to ensure issues are resolved. • Perform other job-related duties as assigned. Education • Bachelor's Degree preferred • Equivalent combination of education and professional work experience required Experience • Minimum 1 year supervisory, leadership experience responsible for overseeing the activities of others, OR • 1 year Quality experience (CSA/CSAb) required OR • Completion of CSL Plasma Leadership Development program Additional Comments • Maintain company Technical Training certification • Knowledge of ever-changing and complex government and industry regulations, and ability to monitor compliance with these regulations • Monitor and manage entire financial responsibility of the center • Proficient in English Working Conditions (physical & mental requirements) • Ability to make decisions which have significant impact on the department's creditability, operations and services • Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Overnight travel required up to 10% of the time • Generally spends 80% of the time standing and walking and 20% of time sitting • Occasionally lift and carry up to 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes working with freezers and various odors • Exposure to human source products and various chemicals including isopropyl, ethyl alcohol, carbon dioxide, iodine, bleach, germicide solution, etc. • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Fast paced environment with frequent interruptions All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB Job Description • Bachelor degree in scientific discipline/life sciences or related discipline • 5+ years' experience related to quality and regulatory/ Plasma industry experience • Demonstrated leadership/supervisory experience • Knowledge of government and industry regulations #CB

What's in it for you?. The Director/Senior Director of Clinical Data Management and Clinical Programming (CDM/CP) will be responsible for managing, leading, and directing all CDM/CP planning and operational activities to meet corporate objectives within timelines and budgets. The position will be responsible for building and leading the CDM/CP function and team, setting vision for the department including strategic direction, operations, infrastructure, technology innovation, and talent development. The Director/Senior Director will require strong leadership, organization skills, and broad experience with Phase I-IV clinical trials. The Director/Senior Director will collaborate closely with other functional leaders to design the best solution to meet business needs. The position will be responsible for strategic oversight of Contract Research Organization (CRO) partner and all activities related to data management and clinical programming quality and deliverables. This position will report to the Vice President of Clinical Operations. The Director/Sr. Director will be a key leader on the R&D team who will be responsible for the development and communication of the vision, sense of purpose, and clear operational roadmap for the CDM/CP function within the Clinical Operations Department. We are searching for an individual who will thrive in a fast-paced, innovative environment, has demonstrated excellent interpersonal skills and the ability to develop and maintain key stakeholder relationships. The Director/Sr. Director will be required to possess the skill to analyze complex issues and develop realistic plans, programs, and recommendations to achieve goals by enabling and supporting the CDM function in the production of high-quality data to inform strategic decisions. What will you be doing?: Promote standardization, automation, innovation, process improvement, and technology enhancement in CDM/CP and beyond to increase drug development efficiency. Establish sound CDM/CP processes including SOPs to ensure highest data quality/integrity and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices. Lead or direct CDM/CP activities including CRF/eCRF design, validation programming, discrepancy management, and database development and production. Performs close-out audit, as specified, for closing of study trial in EDC or other databases. Ensure all CDM/CP documentation are complete, accurate and in an inspection-ready state. Champion and lead the development and implementation of policies, standards and process improvement initiatives. Ensure CROs, suppliers, and internal staff meet the highest quality standards per SOPs. Plans, manages and oversees relevant budget control and CRO activities. Provide oversight and guidance, as well as establishing key performance metrics to CROs to ensure highest data quality/integrity and regulatory compliance. May participate in study level document review, e.g. protocols, SAPs, TLFs. Lead strategic decision-making process involving data management issues for ongoing clinical trials. Provide career development and performance management of individual employees. Manage escalated conflict resolution through open communication, teamwork, diplomacy, and mediation. Maintain current professional knowledge of regulatory requirements and industry best practices in relevant areas of CDM/CP, technology advances, and quality assurance. Resolve complex strategic issues in creative and effective ways, within the CDM/CP space but also across the broader Clinical Development space. What are we looking for?: Bachelor's or Master's degree, scientific area preferred. Requires minimum of 15 years of CDM/CP experience in a pharmaceutical/biotech or CRO setting. 10+ years of line management experience. Expert knowledge of CDM/CP processes, EDC systems, database programming, quality management and technology advancements in the field of data management. In-depth knowledge of FDA regulations, GCP, GCDM/CPP, CDASH/CDISC, MedDRA/Who Drug dictionaries and ICH guidelines. Extensive experience in designing, leading and championing cross-functional projects with internal partners and CROs. Strong experience in Inspection Readiness and Regulatory considerations. Strong track record of line management and supervisory experience of CDM/CP and CP staff, proven leadership skills to lead and inspire staff including consultants. Willing to travel as business requires. Outstanding influencing/negotiation skills. Excellent interpersonal, communication, and leadership skills. Logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities. Ability to prioritize and to adapt quickly to changing business conditions with a proactive and positive attitude. Ability to prioritize workload and meet deadlines, demonstrate effective use of time and manage multiple priorities simultaneously. Demonstrated problem-solving abilities; Capable of actively identifying project challenges and risks and proposing appropriate solutions to issues. Identifies and implements process and standards to improve the effectiveness and efficiency of the data management team. How will you grow with us?. This position will allow you to take on a key leadership role and join a dynamic, collaborative team. As a rapidly growing company with multiple assets in development and key regulatory milestones on the horizon, you have an opportunity to leverage your expertise and continue to develop and shape the growing CDM/CP group. If you are looking to be a part of an innovative and fast-paced environment, join our team!.

Operations Management & Assurance Director 201792 Jersey City, NJ, Dallas TX, Tampa, FL or Boston, MA. Are you ready to explore a world of possibilities?. Join our DTCC family, and you'll grow your expertise and become the best version of you. As you embark on a new journey, you'll tackle challenges with flexibility and grace, learning new skills and advancing your career while having the time of your life. Why you'll love this job: We are looking for a Director level senior person to join the Model Risk Management group ("MRM"), which is responsible for all aspects of Model Risk Management at DTCC from model governance, operations management & assurance ("OM&A"), independent model validation to model performance monitoring ("MPM") and back testing ("BT"). The Director level incumbent will work closely with the heads of model validation and model governance within MRM group to establish assurance of quality and consistency of operations for all MRM related processes across the firm and provide oversight of adherence to the standards of excellence for MRM activities including consistency of model documentation, validation reports, MPM reports, model inventory operations, etc. This position has extensive people, project and methodology responsibilities. It is a high-visibility position with frequent and in-depth interactions with multiple internal and external stakeholders such as Quant groups, Market and Liquidity Risk, IT, Management, Clients, Internal Audit and our Regulators. Successful candidate is expected to quickly achieve a comprehensive understanding of the DTCC's businesses and be able to apply industry best practices to DTCC's business context. Your Responsibilities: Manage the OM&A team. Set up and maintain best-in-class requirements for all MRM processes and standards and provide oversight for their compliance. Recruit and management competent personnel for conduct OM&A activities. Interface with the auditors and Regulators on all aspects of OM&A review and oversight. Perform regular as well as ad hoc analysis to identify gaps in quality of various MRM processes, design solutions and implement those solutions for MRM and across the company when needed. Coordinate MRM review activities, including resource & validation planning, status updates & tollgates, management reporting and partnership with lines of business. Challenge MRM peers to ensure the best-in-class model risk practices are achieved. Mitigates risk by following established procedures, spotting key errors and demonstrating strong ethical behavior. Talents Needed for Success: Minimum of 10 years of related experience. Bachelor's degree preferred with Masters or equivalent experience. Broad expertise in quantitative finance on valuation models (curve building methodologies, term structure models, option models, credit Operations models), and risk management models and methodologies (greeks, VaR, back testing, stress testing). Knowledge of prepayment modeling, MBS pricing and risks is a plus. Deep understanding of the regulatory environment surrounding model risk management (SR11-7 and SEC Covered Clearing Agency Standards). Experience and expert knowledge on VaR modeling and VaR model back testing methodologies. Strong mathematical background, especially in probability theory, stochastic processes, and PDE's.

About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . The primary function of Purchasing is to economically and efficiently purchase goods and services commensurate with AbbVie policies and objectives, while adhering to a strict standard of business ethics and integrity. Responsible for managing suppliers effectively and providing high levels of customer satisfaction. The Purchasing Lead works closely with affiliate management and employees, at the direction of the Regional Purchasing Assoc. Director. This position negotiates, develops, and implements agreements that maximize value and support client initiatives, standardizes materials, services and suppliers. The Purchasing Lead is delegated the authority to commit company funds. This position will work on the definition and resolution of known or anticipated problems in value, quality, feasibility, and specifications in the procurement of goods and services, while contributing cost savings and other value-added activity to support customer needs and expectations. Responsible for sourcing, bidding, negotiating, contracting, and purchasing goods and services in alignment with agreed category strategies. Execute the competitive bidding process in accordance with the Organization's Purchasing Policy Understand the Organization's approved buying channels and contracting policy for goods and services and help guide requestors to the appropriate buying channel. Develop and maintain a supply base that ensures the best value for quality, delivery, pricing, service, etc. Includes over-sight of all new vendor requests, in alignment with preferred supplier networks and relevant category strategy. Support and implement preferred supplier network (PSN's) for certain spend categories and help drive spend to these suppliers. Proactive management of local suppliers including anticipation, resolution, and communication. Analyze supplier performance using established rating systems (eg supplier metrics program, (e.g SRM) suppliers' goals, etc.). Identify, develop, and implement standardized buying practices to ensure adequacy of supply chain. Educate requisitioners on the same. Seek innovative solutions for the procurement process, develop action plans and participate in cross-functional, cross-divisional teams. Effectively develop and negotiate confidentiality agreements and any other agreement in alignment with agreed category strategies, at a financial approved and authorized for the position. Meet regularly with internal customers and support functions to ensure customer satisfaction and continuous improvement, including monthly / regular reporting and updates. Support AbbVie category strategies and obtain client approval of category strategies. Communicate with the relevant Category Manager to help identify major opportunities. Develops and maintains necessary files and records to maintain compliance and maximize performance in completing job functions. Perform on-going analysis and cost reductions to ensure the lowest overall cost and highest possible value Assures affiliate purchasing practices are compliant with Purchasing and Supplier Management (PSM) policies and procedures. Understand and apply cultural awareness with foreign business entities. Seek, develop and maintain business relationships with regional colleagues, suppliers and clients. Use of procurement tools including but not limited to: SAP, catalogues, eProcurement, economic indicators and contract management, etc Responsible for the Supplier Diversity Program and Diversity Reporting, as required. Includes assurance that Minority Certifications are updated as per expiration dates, spend goals are established, agreed upon and reported on a yearly basis, etc Qualifications Required Qualifications Bachelor's degree in Business or related discipline. A minimum of 6 years of progressive experience in a purchasing agent / buyer role, preferably in Pharmaceutical industry Analytical, problem solving and interpersonal skills. Written and verbal skills enabling effective communication with all levels of management. Knowledge of purchasing policy. Contract negotiations experience Preferred Qualifications CPM certification desired (or equivalent) Experience with SAP (SRM, ECC), e-Sourcing and contract management tools preferred, but not required. Individuals must be self-motivated with great follow-up skills and be able to work independently. Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

County of Los Angeles Department of Public Health Substance Abuse Prevention and Control Health Program Manager II Position: Exempt Monthly Salary: $10,258 Fully Paid Medical/Dental Insurance Grant funded project through June 30, 2022 The following provides a general description of duties and a more specific description of requirements for the Health Program Manager II. Please note that the summary of responsibilities and required abilities identified below are not to be construed as an exhaustive statement of duties, responsibilities, or requirements. The Health Program Manager II has immediate charge of a large-sized public health program or comparably sized segment of a major public health program within the Department of Public Health. Minimum Qualifications: • Master's Degree from an accredited institution in a field related to the core business of the program. • Ability to direct program administrative functions and support services; and, develop and implement solutions to complex problems within the program. • Ability to perform the full range of administrative and technical supervision to plan, assign, oversee and plan the work of subordinate staff; provide technical guidance and support to staff where appropriate. • Ability to develop, interpret and implement policies and procedures; and advise and make recommendations to bureau administration on policy issues involving the work of the program; and • A valid California Class C Driver License or the ability to utilize an alternative method of transportation when needed to carry out job-related essential functions. Desirable Qualifications: • Experience in directing all activ ities of a large behavioral health program, including planning, implementation, administration, and evaluation. • Experience in developing, negotiating, implementation and management of budget. • Knowledge of the development, monitoring and compliance of contracts specific to the program. Job Requirements: The general duties of the Health Program Manager II include, but are not limited to: • Direct all activities of the program, including planning, implementation, administration, and evaluation. • Perform the full range of administrative and technical supervision to plan, assign, oversee, and evaluate the work of subordinate staff; provide technical guidance and support to staff where appropriate. • Develop, implement, and interpret policies and procedures and advise and make recommendations to bureau administration on policy issues involving the work of the program. • Participate in the development, negotiation, implementation, and management of the budgets for the program; ensure that budget and contract allocations reflect program priorities and take corrective action as necessary. • Direct program administrative functions and internal support services; and, develop and implement solutions to complex problems within the program. • Interface and collaborate with community groups and public and governmental agencies. • Participate in the development, monitoring, and compliance of contracts specific to the program. • Direct the review and analysis of existing and proposed federal, State, and local laws, regulations, legislation, or policies affecting the program. • Supervise and lead division-wide strategic planning groups in the development of strategies and priorities for the division. • Plan and lead the assessment of programmatic activities affecting the health and well-being of individuals served by the program and coordinate the development and dissemination of findings and recommendations developed from the evaluations conducted. • Other duties as assigned, may be temporarily reassigned to COVID-19 assignments as needed. The Health Program Manager II of the Prevention Services Branch directs the efforts to support individual and community-level initiatives that reduce substance use and related adverse health and social outcomes, and implement locally driven efforts to change conditions and norms that impact community health and health equity. This position reports to the Director of the Substance Abuse Prevention and Control and leads the Prevention Services Branch. Job Responsibilities of the Health Program Manager II include, but are not limited to: 1. Directs and oversees all activities related to the development, implementation, administration, and evaluation of an organized system of three prevention program branches, including implementation of all levels of the six-layered Spectrum of Prevention that promotes a comprehensive public health strategy for prevention. 2. Interfaces with external and internal stakeholders, including other County departments, local, State, and federal agencies, provider associations, and community groups to integrate efforts to identify and address community trends and emerging needs, reduce high-risk behaviors, foster healthier community environments that will lead to reduced alcohol and other drug use, and support SUD recovery; coordinates with and makes recommendations to executive management to improve prevention services and keep management abreast of prevention activities. 3. Hires, trains, and provides administrative and technical supervision and guidance to unit directors/managers and staff in charge of primary and secondary prevention program services, including Provider Education and Risk Reduction Initiatives Unit, inclusive of the naloxone and needle exchange programs, provider education, and the HEART Collaborative; Community Wellness Initiatives Unit, inclusive of the Community and Youth Engagement, and Family Resource Centers Sections; Student Wellbeing Centers Unit, inclusive of health education services at Los Angeles County high schools; and Early Intervention Services Unit, inclusive or the Driving Under the Influence and Penal Code 1000 programs. Additionally, collaborates with the Strategic, Regulatory and External Affairs (SREA) Branch to support organizational alignment with strategic planning and marketing efforts; and with the Clinical Services and Analytics (CSA) Branch to support collaboration regarding surveillance, research and evaluation efforts conducted by the HODA Unit. 4. Directs efforts to systematically improve coordination and delivery of prevention and treatment services and support policy-oriented solutions, including development and management of internal and external policies, procedures, protocols, standards of quality assurance, and/or practices designed to improve coordination of the work among SAPC divisions/units, the Health Agency of Los Angeles (HALA), contractors, and other partners in the health care system, including coordinating responses to emergent primary and secondary SUD prevention efforts and collaborating with Treatment Services, other DPH programs, County departments, and communities to integrate prevention into services provided; negotiates, develops, and manages budgets for each branch of prevention to improve effectiveness and efficiency of prevention services. 5. Directs and prepares reports for use in prevention program planning and development efforts, including review and analysis of protocols and procedures from other jurisdictions, proposed and existing legislation, State and federal regulations, and grant funding opportunities. 6.Directs and oversees the ongoing analyses and research of various State and federal SUD prevention related legislation for programmatic and fiscal impact and makes recommendations to executive management. 7. Directs and oversees internal and external prevention-related communications, in coordination with SREA and CSA Branches, as well as DPH Office of Communications and Public Affairs, regarding marketing and media message initiatives, media inquiries, requests for information, documents for public distribution, and investigations on problems and issues concerning SUD prevention services. 8. Other duties as assigned, may be temporarily reassigned to COVID-19 assignments as needed.

About CSL With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! Job Description Job Description • Ensure center is "inspection ready" at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation. Prepare regular reports to center, area and corporate quality management as to the state of quality and systems at the center. • Manage site Quality Control program including but not limited to calibrations management, monitoring of compliance to defined processes e.g. sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis of KPIs, root cause and failure mode impact assessment and change management. • Lead and develop direct reports ensuring they are competently skilled to perform their QA roles. Lead by example; consistently motivate staff through education to high levels of competency that drive success in a dynamic and regulated environment. Upon proper review with center and quality management, recruit, hire, conduct performance reviews and enact corrective actions, up to and including termination. • Participate with management to develop programs and methods to streamline center processes resulting in improved customer/donor service, product yields and financial results while maintaining compliance and quality. • Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Report concerns or deficiencies to area personnel and/or area management immediately. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues of deficiencies. • Lead and function as the key quality representative for site supplier, customer and regulatory audits. Lead center review of findings, coordination of remediation (CAPA), if needed and successful closure of timely audits. Utilize quality tools and applications to facilitate understanding of issues and documentation. • Maintain clean efficient work environment and ensure sufficient operating supplies and availability of forms, as needed. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine audits of internal procedures and documentation, as necessary. Promote safety in all actions. • Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure HR compliance and ensure center management is doing the same. • Comply with all federal, state and local regulatory and company policies and procedures. • Responsible for notification to the ADOQ for any event that negatively affects the safety, quality, identity, purity or potency of the product that results in pausing or disruption of business. If necessary, notification must be elevated to any of the following, Regional Director, Associate Director of QA, Divisional Director or Director of Quality Systems and Assurance. • Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper immune programs at the center if applicable. • Lead investigations and deviations to determine root cause, correction/preventative actions and effectiveness checks. Monitor CAPA's and effectiveness checks to ensure issues are resolved. • Perform other job-related duties as assigned. Education • Bachelor's Degree preferred • Equivalent combination of education and professional work experience required Experience • Minimum 1 year supervisory, leadership experience responsible for overseeing the activities of others, OR • 1 year Quality experience (CSA/CSAb) required OR • Completion of CSL Plasma Leadership Development program Additional Comments • Maintain company Technical Training certification • Knowledge of ever-changing and complex government and industry regulations, and ability to monitor compliance with these regulations • Monitor and manage entire financial responsibility of the center • Proficient in English Working Conditions (physical & mental requirements) • Ability to make decisions which have significant impact on the department's creditability, operations and services • Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations • Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens • Overnight travel required up to 10% of the time • Generally spends 80% of the time standing and walking and 20% of time sitting • Occasionally lift and carry up to 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes working with freezers and various odors • Exposure to human source products and various chemicals including isopropyl, ethyl alcohol, carbon dioxide, iodine, bleach, germicide solution, etc. • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas • Fast paced environment with frequent interruptions All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB Job Description • Bachelor degree in scientific discipline/life sciences or related discipline • 5+ years' experience related to quality and regulatory/ Plasma industry experience • Demonstrated leadership/supervisory experience • Knowledge of government and industry regulations #CB

Associate Director, Regulatory Affairs CMC Position Summary Reporting to the Sr. Vice President of Regulatory Affairs and Quality Assurance, the successful candidate will lead the CMC regulatory function and collaborate cross‐functionally to develop the CMC regulatory strategy, provide guidance to the CMC subject matter experts, and drive CMC regulatory submissions to facilitate the global development of Avidity compounds. Key Responsibilities Lead preparation, coordination, review, and maintenance of CMC content in regulatory submissions (e.g., INDs and CTAs, annual reports, Briefing Documents, NDA/MAA), to ensure timelines and corporate goals are met Represent regulatory function in CMC subteam, and develop CMC regulatory strategies within that team Provide regulatory CMC advice and direction, including the interpretation and application of global CMC feedback, regulations and guidance Manage technical assessments of CMC source documentation and responses to technical questions on document content Proactively identify potential CMC program and/or submission risks and implement appropriate regulatory mitigation strategies to support successful submissions Oversee and ensure compliance with quality assurance and regulatory procedures and work practice Initiate and/or contribute to process improvements which have an impact on Regulatory Affairs or other departments. Involvement in preparation for and management of CMC interactions with Health Authorities Train, mentor and supervise, as needed, employees, consultants/contractors in Regulatory Affairs Maintain a positive team spirit and lead by ethical principles Qualifications and Requirements Bachelor's Degree, at a minimum, (advanced degree preferred) in life sciences or chemistry, with 5-8 years of experience in Regulatory Affairs with a CMC focus within a biotechnology company Established working knowledge of regulatory guidelines and regulations, US and international Direct experience leading regulatory CMC aspects of IND/CTA/NDA/MAA submissions, experience with both biologics and small molecules strongly preferred Demonstrated evidence of writing CMC portions of high-quality regulatory documents Strong eCTD knowledge and regulatory writing skills Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with management, CMC/cGMP Quality Assurance, and contract manufacturing organizations Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority‐setting to work effectively in a dynamic environment to meet aggressive timelines Self‐motivated, self‐disciplined, and able to function independently as well as part of a team Strategic agility, strong critical and logical thinking with the ability to analyze and propose solutions to problems Excellent computer proficiency (MS Word, Excel, PowerPoint, Adobe Acrobat)

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at . Be a part of the future of Precision Medicine! Our mission is to improve the human condition by bringing the power of precision medicine to labs, partners and patients globally. In the Companion Diagnostics Business (CDx), our team partners very closely with leading pharmaceutical companies to develop, manufacture and commercialize highly regulated medical devices which are critical for physicians to help select therapies for their patients. Become a part of a growing and dedicated team that does truly inspiring work in the field of Precision Medicine. Our employees are passionate about their contributions because there is a very direct connection to helping patients with cancer. This is an exciting opportunity to be part of a growing team with proven record of success in global registrations in Companion Diagnostics in the field of Oncology. In this role you will have opportunity to closely work with the group of approximately 20 Regulatory Affairs and Quality Design Assurance professionals, managing 3-6 direct reports. Staff members are located in US, China, Japan and EU. The successful candidate must be a strategic thinker, able to evaluate and act on various complex scenarios involving co-development programs of drug and diagnostics, with ability to manage aggressive timelines. Besides strong regulatory affairs expertise in IVD's, the successful candidate is also a strong people manager, able to work with the Director of this group to ensure all Regulatory Affairs and Quality Design Assurance systems are established, implemented, and maintained in accordance with applicable standards for the company. In this role, the ideal candidate Works closely with CDx functional heads in establishing and implementing CDx business and strategic goals Develops and implements strategies for timely submission and approval of regulatory submissions for Companion/Complementary Diagnostic products Interacts and collaborates with pharmaceutical partners in drug and diagnostic co-development programs Ensures the accurate and timely preparation of regulatory submissions and reporting in accordance with company goals, regulatory requirements and partnership contracts Interacts with the FDA and other regulatory agencies in connection with submission, approvals, and audits Participates in Joint Steering Committees and Joint Project Teams as the senior representative of regulatory affairs in the Companion Diagnostics division Prepares and presents project status reports, strategy and initiatives to CDx leadership teams, Sr. DGG staff, as it relates to regulatory affairs Works across Agilent DGG in formulating regulatory processes/procedures and shares best practices/knowledge with regulatory colleagues across Agilent Stays abreast of global IVD regulations and guidance's, especially those relevant to Companion Diagnostics This is a remote role