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At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder's world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Respect, Science, Courage and Collaboration and it reflects who we are and the environment we are creating. The Senior Director of Regulatory and Quality is responsible to build and lead the Regulatory, Quality Assurance (QA) and Quality Control (QC) functions across all regulated programs and processes. The Senior Director and their team will work alongside our Product Development and Operations teams, providing regulatory and compliance guidance in support of all Lyell GXP functions, including but not limited to, internal and external manufacturing and testing, non-clinical studies and clinical trials. You will be accountable for ensuring that all products in the Lyell portfolio have a successful non-clinical, clinical and CMC regulatory strategies and submission execution plans. This individual should bring both a track record of successful regulatory approvals that demonstrate core capability in product development and commercialization, as well as a passion to challenge conventional paradigms and influence global Health Authorities. You will serve as a key leader of the Technical Operations and Clinical Development teams and will be responsible for overseeing the development and implementation of Lyell quality management systems and will establish Strategic Regulatory and Quality Objectives in support of development programs and corporate goals. This position will drive and cultivate a culture of quality throughout Lyell to support compliance with all applicable regulatory requirements, guidelines, and corporate standards, policies, and procedures. Essential Functions: Regulatory Affairs Manage proper filing of all required compliance documents, submissions, registrations in accordance with company business objectives. Ensure overall compliance with regulatory requirements (safety reporting, annual reports, investigator updates). Maintain current working knowledge of FDA and global regulatory requirements. Interact with Health Authorities to define regulatory strategies and secure approvals. Provide regulatory leadership and oversight for Lyell's overall product development portfolio. Ensure departmental and program regulatory objectives are aligned with overarching goals of Lyell and product development. Provide regular communications and updates to management as well as liase with external partners and collaborators. Ensure Lyell has a process for development of regulatory intelligence in areas of key importance and influence regulatory policies and guidance through active participation in commenting processes, conferences, etc. Ensure development of and compliance with internal SOPs and policies regarding regulatory operations, document management and communication. Quality Assurance Establish and optimize Lyell Quality Management System (QMS) processes including Change Control, Document Control, Risk Management, Deviations, CAPA, Training, Product Complaints, Audits, and Vendor Qualification. Ensure alignment of QMS across Lyell sites. Lead the development and reporting of Quality metrics and periodic reporting depicting GXP compliance trends and any areas of risk with associated mitigation plans. Develop and create Lyell Quality infrastructure and strategic direction in conjunction with Clinical Operations and Manufacturing. Provide guidance on GCP compliance matters within clinical study teams. Establish and maintain adequate GXP training programs to support aggressive corporate growth plan. Serve as an escalation point for corporate quality issues including investigation, recalls, deviations, CAPA, change controls, audits, validation and training. Ensure that the company, its contractors and vendors are prepared for FDA and other Health Authority audits. Coordinate and host all GXP inspections. Develop plans and programs to support continuous quality improvement. Develop and effectively manage department annual operating budgets for QA. Quality Control Oversee the development and implementation of QC procedures and policies related to Lyell and vendor cGMP operations. Ensure that Lyell QC laboratories are maintained at a high standard of cleanliness and organization, equipment maintenance and calibrations are performed, and cGMP documentation is completed, reviewed, and archived in a timely manner. Work with key stakeholders including QC lead to develop execution plans for increasing capacity and throughput of QC operations. Collaborate to identify and mitigate risks in QC operations that could negatively impact the quality of patient therapies. Support corporate drive to implement Lean principles to increase quality and productivity. Provide Leadership Provide exceptional leadership skills to the organization including hiring, mentoring and developing Regulatory and Quality staff. Develop a vision, strategy, and plans that are innovative, forward-thinking and based on sound business judgement, considering scalability and sustainability. Use strong communication and teamwork skills to build strong relationships with stakeholders. Champion implementation of new technologies and systems. Ensure a culture of strong GXP compliance and risk management across Lyell. Role model Lyell Values and Lean Leader principles to establish a continuous improvement culture. Experience: A minimum of 15 years of work experience in the biotechnology industry with at least 10 years of progressive responsibility in Regulatory and Quality. 5 years must be in management or leadership role. Expert knowledge of FDA, EMA, MHRA and ICH regulations and guidelines. Experience in hosting domestic and global Health Authority inspections. Experience preparing, reviewing and executing regulatory documents to support clinical studies. Experience working with US and EU CMOs, suppliers, CROs and clinical sites. Experience with assessing new technologies in fast-paced, learning organization; preferably in a cross-functional setting where impact of new technologies is evaluated across research, development and commercial organizations. Experience is all phases of drug development; experience with cell therapy desirable. Extensive working knowledge of GXP regulations and experience interacting with regulatory agencies. Demonstrated ability to build effective, efficient teams, and drive change within organizations. Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills. Motivated to work independently as well as in teams. Education: BS/MS in a scientific discipline or related discipline. Additional Skills: Must have excellent change management, oral and written communication skills. Ability to work independently and collaboratively among cross-functional teams. Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities. At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws. We've learned from experience that some of the best people don't always match our requirements perfectly - if you're interested and think you could fit, please don't hesitate to apply.

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 . Key Responsibilities: Role Will Either: Supports and monitors the operational aspects of RQS business portfolio for cross-RQS capital projects: Manages RQS Budget Ready to Go (RTG) and Ready to Give Up (RTGU) process; Manage Intake, tracking, communication, end of year summary, and reconciliation with Finance and IR portfolio managers on Ready to Go items; Develops, monitors and provides LBEs for RQS General Capital budget and authors Request for Capital Expenditures (RCEs) as needed to acquire necessary funds; Provides project management support for Capital and Functional financial cycle activities and any other functional projects as needed: Prepares status reports and dashboards using standard templates, tracks risks and mitigation plans; tracks issues and facilitates resolution; schedules team meetings; establishes agendas, keeps minutes, manages timelines, creates deliverables and gains approvals, manages artifacts of historical documents); Manages and support the creation of process deliverables (tracking spreadsheets, business cases, PowerPoint summary and visuals) for RQS Capital and RQS Ops Functional Budget Cycles including LRP, Plan and capital project monthly LBEs. Develops RQS cross-functional project proposals for the Long-Range Planning (LRP), Plan and budget planning efforts. Maintains, adapts, socializes and shepherds the utilization of RQS Resource Model to forecast people resource needs based on AbbVie Pipeline during financial cycles and acquisition planning. Or the Role will: Responsible for executing the end to end contract process for all RQS including assisting with planning, development, training, ongoing enhancements, reporting, and relationship with Vendor Management/Consulting stakeholders; Liaison for Third Party Worker programs; managing all related activities including initiation of the request, management of the request process, reconciliation, analysis and budget forecasting. With direction from Operations Director, responsible for completing cross functional projects and strategic initiatives related to RQS Business Operations deliverables. Gains buy-in from management and other appropriate parties. Both Roles Will Be: Responsible for suggesting process efficiencies related to their business operations area and contributes to the identification of gaps. May be assigned to lead change efforts to current process with a focus on continuous improvement to support and build culture. Provides input to procedures and work instructions to support the vision and strategy for to their specific business operations area. Create/maintains process flow diagrams depicting activities. Develops and delivers relevant training to Business Owners, Vendors, and other appropriate parties. Possesses a working knowledge of each of the RQS business functions. Demonstrates knowledge of the product life-cycle business processes, and regulations in the RQS functions. Works with RQS management to develop long-term strategies for business performance optimization within RQS. Establishes effective working relationships with peers and stakeholders across related and partner functions such as IT, vendors, Purchasing, Kelly Services, Legal, Finance, CCG, and OEC. Demonstrates knowledge in utilizing multiple systems/software tools (Innotas, QUEST, SRM, excel, Powerpoint, Sharepoint, Vendor Master, Magellan, Midas, SRM, Salesforce, Org Plus, Fieldglass) to capture, read, analyze, and report pertinent data. Qualifications High School diploma or equivalent and 12 years' experience or Bachelor's degree required. Bachelor's degree preferred. Project Management Certification a plus (e.g. Project Management Institute (PMI) Project Management Professional (PMP) certification preferred. Minimum 6 years related experience with Bachelor's degree or 12 years' with High School diploma required. 3 years pharma, health care or industry related experience preferred. 3 years' experience in a business operations role; and/or experience in finance/accounting/procurement preferred. Proven leadership skills and presence required. Experience working in a complex and matrixed environment required. Robust communication skills both oral and written required. Ability to craft compelling business cases and sell new ideas preferred. Minimum of 6 years project planning and management experience including successful implementation of business and/or technology initiatives preferred. Experience analyzing complex business problems and facilitating the design of innovative solutions preferred. Experience managing contracts and vendor management processes required. Broad experience in business operations role preferred. Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel Yes, 10 % of the Time Job Type Experienced Schedule Full-time Job Level Code M 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.

Position Overview Nektar has an exciting opportunity for a Sr. Director, Quality Assurance GMP to join their QA team. The Sr. Director, Quality Assurance GMP is responsible for providing leadership for all GMP Quality Assurance activities at Nektar San Francisco, and, in collaboration with other corporate QA leadership and all GMP activities across the company. ESSENTIAL DUTIES AND RESPONSIBILITIES Establish and manage GMP policies and procedures to ensure that products are developed, manufactured, and packaged consistent with appropriate regulations and requirements. Develop and implement contemporary, phase-appropriate quality systems and practices that ensure appropriate metrics and process indicators to drive compliance and continuous improvement. Manage interactions with regulatory agencies during compliance inspections. Work in collaboration with departments to develop and ensure readiness for inspections. Establish and manage appropriate policies and procedures to ensure ongoing regulatory compliance for clinical and commercial products. Develop and implement appropriate regulatory systems to ensure required communication with FDA, or other regulatory bodies, are maintained (e.g., adverse event reports, annual product reviews, annual reports, field alert reports, recalls, supplements, and advertisement and promotional labeling changes). Assist marketing partners with foreign regulatory filings. Provide input and guidance to CMC development activities to ensure robust data packages to support regulatory submissions. Work to establish processes and systems that support collaboration and compliance across an extended partner network. Provide leadership for intra-company quality teams in support of corporate collaborations. Support the evaluation/selection potential future contract manufacturing organizations (CMOs). Ensure quality agreements are in place at CMOs to ensure adherence to regulatory requirements. Provide quality input in technology transfers to CMOs. Ensure quality assurance procedures (e.g., change control, investigations, CAPAs, OOS/OOT) are adhered to at CMOs, and, if needed, assist in resolution of associated issues. Oversee internal and external audits for GMP activities. Lead investigations and resolve potential product quality issues to improve efficiency. Responsible for overseeing the review of data and release of all clinical and commercial products and ensure that the product characteristics meet appropriate quality specifications and regulations/guidelines. Oversee review and approval of procedures, production records and specifications. Represent Quality Assurance on cross-functional project teams. Work with abstract ideas or situations across functional areas of the business on complex issues where analysis of situations or data requires an in-depth knowledge. Interact internally and externally with executive level management, requiring negotiation of extremely critical matters. Participates in corporate development and evaluation criteria for projects, programs, and personnel. Responsible for hiring and managing internal and external personnel. Select, develop, and evaluate personnel to ensure the efficient operation of the function. Provide direction and leadership to staff. Establish realistic goals and objectives. Plan, direct, and monitor work activities such that goals and objectives are accomplished efficiently, completely, within established timeframes, and in compliance with department SOPs and cGMP regulations. Ensure training of all GXP personnel. REQUIREMENTS BS degree, or equivalent, in a pharmaceutical-related field with a minimum of 15 years experience in Quality and/or manufacturing support, including at least 10 years of supervisory experience. Experience with electronic documentation management systems. Extensive internal and external auditing experience. Comprehensive knowledge of current Good Manufacturing Practices and the ability to correctly interpret cGMP minimum standards. Working knowledge in quality sciences, statistics, and computer-based operations. Strong verbal and written communication skills are required. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.

Location: 87-227 St. Johns Rd. Waianae, Hawaii 96792 Position Summary: Plan and carry out daily program and activities for a group of infant/toddlers Supervises: Not applicable Schedule: Full -Time Essential Job Functions (fundamental Teacher Assistant I responsibilities): Support a learning Center environment. Help with appropriate daily activities for children. Maintain a safe and healthy nurturing environment for children. Establish a safe and healthy nurturing environment for children. Supervise children for safety. Arrange classroom daily and prior to Fall and Summer sessions. Change diapers and/or wet or soiled clothing. Keep the environment clean and orderly; bend and pick up toys, wipe tables and chairs, etc. Attend staff meetings, school programs, In/Service Training. Secondary Job Functions (tasks that can be delegated): Fill out injury reports. Answer the telephone and record messages according to company format. Additional Responsibilities (expected of all staff): Relate joyfully and sensitively to children. Greet parents cheerfully. Greet children individually, warmly, and cheerfully. Give loving personal attention to children when they need it; comfort crying, dry tears, wipe noses, give hugs and reassurance. Be conscious of cleanliness of children; soiled clothing must be changed, children's hands and faces kept clean. Report all sign of illness, injury or possible abuse and unusual behavior to the Center Director. Use group management and discipline that is positive, consistent, and appropriate. Maintain a positive attitude toward children, parents, and coworkers. Communicate with children, parents, coworkers, and Director. Work cooperatively with Director and other staff towards maintaining a quality program for children. Personal Demands of the Position: Emotional maturity and stability. Emotional stamina to work positively with young children for the length of scheduled workday. Mental stability; patient, flexible, sense of humor, positive, consistent, dependable, cooperative. Sufficient security and judgment to handle crisis situations. Able to take supervision and correction constructively. Able to positively supervise aides and other personnel when required. Clean personal hygiene. Physical Demands of the Position: Bending, squatting, kneeling, crawling, sitting on low chairs or on the floor. Lifting children weighing up to 45 pounds. Pushing, pulling, lifting furniture. Detecting unsafe situations by sight or sound. Moving quickly to intervene in unsafe situations. Position Content This job description is not intended to be and should not be construed as an all-inclusive list of all the responsibilities, skills, or working conditions associated with the position. While it is intended to accurately reflect the position activities and requirements, management reserves the right to modify; add or remove duties and assign other duties as necessary to meet the needs of the children, the program and the Center. QUALIFICATIONS: Clear a local and national criminal background check. Clear an employment history check. Free of TB. At least 18 years of age. High School Diploma or equivalent. Current First Aid certification. PREFERRED QUALIFICATIONS (other helpful qualification or experience): Hold a current CPR certificate. #CB #CB

Location: 5919 Kalanianaole Hwy Honolulu HI 96821 Position Summary: Plan and carry out daily program and activities for a group of preschool children Supervises: May work with and supervise an assistant teacher or aide Essential Job Functions (fundamental teacher responsibilities) Establish and maintain a learning Center environment that supports the growth and development of children Plan and conduct developmentally appropriate daily activities for children Create developmentally appropriate lesson plans using required forms and turn in as scheduled Observe, record, and report significant individual and group behavior Be responsible for written communications to parents; notes, newsletters, end of year written report on children Establish a safe and healthy nurturing environment for children Supervise children for safety by sight and sound at all times. Assure 15 min. head counts are recorded on required forms Attend staff meetings, school programs, In/Service Training Complete child assessments and parent teacher conferences as scheduled Display teaching excellence for other staff; role model, share professional and technical information. Secondary Job Functions (tasks that can be delegated) Establish and maintain a learning Center environment that supports the growth and development of children Write up lesson plans. Write communications to parents; notes, newsletters, year end report. Fill out injury reports. Set up classroom daily and prior to Fall and Summer sessions. Change diapers and/or wet or soiled clothing. Keep the environment clean and orderly; bend and pick up toys, wipe tables and chairs, etc. Answer the telephone and record messages according to format. Additional Responsibilities (expected of all staff) Relate joyfully and sensitively to children Greet parents cheerfully Greet children individually, warmly, and cheerfully\ Conduct Daily Health check when greeting child and have them was hands upon arrival Give loving personal attention to children when they need it; comfort crying, dry tears, wipe noses, give hugs and reassurance Be conscious of cleanliness of children; soiled clothing must be changed, children's hands and faces kept clean Report all sign of illness, injury, unusual behavior, or possible abuse to the Center Director. Use group management and discipline that is positive, appropriate, and consistent. Maintain a positive attitude toward children, parents, and coworkers. Communicate positively with children, parents, coworkers, and Director. Work cooperatively with Director and other staff towards maintaining a quality program for children. Personal Demands of the Position Emotional maturity and stability Emotional stamina to work positively with young children for the length of scheduled workday Mental stability; patient, flexible, sense of humor, positive, consistent, dependable, cooperative Sufficient security and judgment to handle crisis situations Able to take supervision and correction constructively Able to positively supervise aides and other personnel when required Clean personal hygiene Physical Demands of the Position Bending, squatting, kneeling, crawling, and sitting on low chairs or on the floor Lifting children weighing up to 45 pounds Pushing, pulling, lifting furniture Detecting unsafe situations by sight or sound Moving quickly to intervene in unsafe situations Position Content This job description is not intended to be and should not be constructed as an all inclusive list of all the responsibilities, skills, or working conditions associated with the position. While it is intended to accurately reflect the position activities and requirements, management reserves the right to modify; add or remove duties and assign other duties as necessary to meet the needs of the children, the program, and the Center. QUALIFICATIONS (For Levels I, II, III) Clear a local and national criminal background check Clear an employment history check Free of TB Completed physical At least 18 years of age EDUCATIONAL QUALIFICATIONS A degree in ECE or Child Development and 6 months experience working with children Bachelor Degree in any field , plus 12 credits in Early childhood or Child Development and 6 month experience working with children Bachelor Degree in Elem. Ed plus 6 credits in Early Childhood/ Child development and 6 months experience working with children 60 credits in a degreed program and a Certificate in Early Childhood Ed ( 16 credits) and 1 year supervised teaching experience CDA (Child Development Associate Credential)and 1 year supervised teaching experience PREFERRED QUALIFICATIONS (other helpful qualifications) Hold a current first aid certificate. #CB

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.Job SummaryWe are seeking an experienced Sr. Manager, Diversity, Equality & Inclusion for our Global Talent Acquisition and Diversity team. This is a remote position and can be located anywhere in the U.S. The Sr. Manager, Diversity, Equality & Inclusion will help drive the execution of CRL's global Diversity, Equality & Inclusion strategy, to create and enable a workplace environment that drives performance in the marketplace, attracts, retains, supports and develops top talent. This role focuses on executing and pulling through opportunities to drive strategy through major, multi-dimensional, enterprise-wide initiatives through project leadership, execution and subject matter expertise. The Senior Manager manages and consults with project teams and advises senior leadership on complex strategic corporate initiatives in the area of diversity, equality and inclusion. The role is expected to have significant interactions and collaboration with senior functional leadership teams, HR, Communications, Legal, managers & employees at all levels. External relationships include other Charles River global functions and sites, consultants, vendors, and marketplace professional associations/ organizationsOther responsibilities related to this role are: Liaise with local 'grass-roots' teams and groups at CRL sites around the world.Coordinate Employee Resource Group key activities and matching with Executive Sponsors.Develop and sustain a centralized calendar of cultural and special celebrations.Design and sustain internal and external web pages.Manage action plans and execute projects related to the DE&I strategy.Data Analysis and Reporting: Design a framework for tracking, reporting, and communication around DE&I metrics and progress. This will be key to holding ourselves accountable toward making progress.Participates in the application process for external recognition awards and external benchmarking surveys.Job RequirementsThe following are minimum requirements related to the Sr. Manager, Diversity, Equality & Inclusion position. Education: Bachelor's degree (B.A. /B.S.) in human resources management, business administration, or related discipline, advanced degree preferred. Experience:Requires a minimum of 8 years progressively responsible experience including 2 years in HR management in a multi-cultural environmentExperience in HR/ HR related fields including Diversity & Inclusion, Culture, Organization Development, HR Business Partnership, and/or Talent Management or related work.Demonstrated success with large, complex, and/or enterprise wide initiatives.Demonstrated experience with leading and managing programs/ projects.Experience in leading change management/ organization development efforts.About Corporate FunctionsThe Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.About Charles RiverCharles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.With over 17,000 employees within 80 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62.At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet

Location:1- 91-1841 Ft. Weaver Rd. Position Summary: Plan and carry out daily program and activities for a group of preschool children Supervises: May work with and supervise an assistant teacher or aide Essential Job Functions (fundamental teacher responsibilities) Establish and maintain a learning Center environment that supports the growth and development of children Plan and conduct developmentally appropriate daily activities for children Create developmentally appropriate lesson plans using required forms and turn in as scheduled Observe, record, and report significant individual and group behavior Be responsible for written communications to parents; notes, newsletters, end of year written report on children Establish a safe and healthy nurturing environment for children Supervise children for safety by sight and sound at all times. Assure 15 min. head counts are recorded on required forms Attend staff meetings, school programs, In/Service Training Complete child assessments and parent teacher conferences as scheduled Display teaching excellence for other staff; role model, share professional and technical information. Secondary Job Functions (tasks that can be delegated) Establish and maintain a learning Center environment that supports the growth and development of children Write up lesson plans. Write communications to parents; notes, newsletters, year end report. Fill out injury reports. Set up classroom daily and prior to Fall and Summer sessions. Change diapers and/or wet or soiled clothing. Keep the environment clean and orderly; bend and pick up toys, wipe tables and chairs, etc. Answer the telephone and record messages according to format. Additional Responsibilities (expected of all staff) Relate joyfully and sensitively to children Greet parents cheerfully Greet children individually, warmly, and cheerfully\ Conduct Daily Health check when greeting child and have them was hands upon arrival Give loving personal attention to children when they need it; comfort crying, dry tears, wipe noses, give hugs and reassurance Be conscious of cleanliness of children; soiled clothing must be changed, children's hands and faces kept clean Report all sign of illness, injury, unusual behavior, or possible abuse to the Center Director. Use group management and discipline that is positive, appropriate, and consistent. Maintain a positive attitude toward children, parents, and coworkers. Communicate positively with children, parents, coworkers, and Director. Work cooperatively with Director and other staff towards maintaining a quality program for children. Personal Demands of the Position Emotional maturity and stability Emotional stamina to work positively with young children for the length of scheduled workday Mental stability; patient, flexible, sense of humor, positive, consistent, dependable, cooperative Sufficient security and judgment to handle crisis situations Able to take supervision and correction constructively Able to positively supervise aides and other personnel when required Clean personal hygiene Physical Demands of the Position Bending, squatting, kneeling, crawling, and sitting on low chairs or on the floor Lifting children weighing up to 45 pounds Pushing, pulling, lifting furniture Detecting unsafe situations by sight or sound Moving quickly to intervene in unsafe situations Position Content This job description is not intended to be and should not be constructed as an all inclusive list of all the responsibilities, skills, or working conditions associated with the position. While it is intended to accurately reflect the position activities and requirements, management reserves the right to modify; add or remove duties and assign other duties as necessary to meet the needs of the children, the program, and the Center. QUALIFICATIONS (For Levels I, II, III) Clear a local and national criminal background check Clear an employment history check Free of TB Completed physical At least 18 years of age EDUCATIONAL QUALIFICATIONS A degree in ECE or Child Development and 6 months experience working with children Bachelor Degree in any field , plus 12 credits in Early childhood or Child Development and 6 month experience working with children Bachelor Degree in Elem. Ed plus 6 credits in Early Childhood/ Child development and 6 months experience working with children 60 credits in a degreed program and a Certificate in Early Childhood Ed ( 16 credits) and 1 year supervised teaching experience CDA (Child Development Associate Credential)and 1 year supervised teaching experience PREFERRED QUALIFICATIONS (other helpful qualifications) Hold a current first aid certificate. #CB

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Lead execution and project management of Global Medical Affairs clinical activities, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The types of clinical activities supported include company sponsored studies (interventional and non-interventional), Expanded Access Programs (EAP), Collaborative External Sponsored Research, and Investigator Initiated Studies (IIS). The Director will take responsibility for the clinical operational strategy and overall delivery (i.e. Operational Project Lead role) of clinical studies or EAP (incl. vendor management and oversight) and will represent GMA Clinical Operations on the program and study teams. This position may require future line management responsibility of Clinical Study Managers, who are primarily responsible for the tactical execution of the study. The Director will be expected to take both strategic and tactical operational roles in order to deliver the study. At this level, the incumbent may also be expected to lead program(s) of studies. Furthermore, the Director is expected to also work in governance and clinical systems related developments and activities. Responsibilities: Work closely with Outsourcing and Legal on RFP, Scope of Work documents, contracts and any other documents necessary to ensure vendors are properly selected and contracted with, in accordance with DS policies and procedures. Oversee contracts once approved with regards to adherence to timelines, budgets and scope of work. Lead the internal and external functional study team(s) to develop a cross-functional, integrated study implementation plan including creation of initial study budget, study kick-off and team meetings. Ensure the timing of all study milestones and the associated budget meet the needs of the overall plan agreed by the Project/Program Team(s). Across all programs, responsible for: • oversight of protocol /protocol amendment development, review and approval process, incl. integration of proper operational delivery aspects and logistics • development or input into all other study related documents including but not limited to ICF, CRF guidelines, project management plans, monitoring plans, QA plans, clinical oversight plans, etc. • Lead site selection and site qualification discussions with functional study team and CRO as required. • provide input into all other relevant study documents related to safety, regulatory, data management, clinical supplies etc. and oversees and manages the related functional study processes Oversee the CRO and other vendors, provides timely strategic and operational input to ensure that the study is executed according to the agreed project plan. Actively conduct study risk assessment and study oversight as well as ensure mitigation and contingency measures are prepared and implemented. Maintain quality and oversight of all study deliverables from start up to delivery of CSR and study archiving through close collaboration across functions, stakeholders and vendors. Ensure all key stakeholders are aligned on the approach and the conduct of global studies/programs including but not limited to Regional Medical Affairs, Regional Clinical Operations, CSPV, Regulatory Affairs, Quality Assurance, Legal/Compliance, Clinical Supply Operations, Global Program Teams, GMAT Leads, GMA leadership. Represent Clinical Operations in Global Medical Affairs program team(s) and with alliance partner(s) and serve as interface for all related Clinical Operation tasks and activities Ensure that relevant synopsis and protocols are reviewed by the applicable GMA review committees. Ensure that global study documentation and tracking systems as well as budget planning and reporting systems are fully implemented and used by all stakeholders accordingly. CRO/Vendor and Quality Oversight Responsible for management of CRO(s)/Vendor performance to ensure adherence to scope of work within timelines and budget at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to senior management or the appropriate governance committee.Create the budget at study start up, and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work (to minimize unwarranted change orders) and budget, so both can be managed appropriately. Clinical Operations Management/General Participate in the development of governance measures, eg. Policies and SOP's related to Global Medical Affairs clinical operations activities, in collaboration with Operational Excellence team. Collaborate with Quality Assurance, QC function and regulatory Operations to implement quality standards across all activities, systems and processes. Support the implementation of CAPA in relation to sponsor's audit or regulatory inspection. Participate in the development and implementation of GMA ClinOps related management, tracking and documentations systems for interventional and non-interventional studies, CESR, IIS and EAP. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: • Bachelor's degree required. A Master's degree in the Life Sciences is preferred. PhD, PharmD is of advantage • ≥ 8 years clinical operations experience in a Pharmaceutical company, and/or Contract Research Organization (CRO). Experience in global clinical study settings and in Medical Affairs preferred. Sound experience in interventional and non-interventional studies as well as IIS and Collaborative Externally Sponsored Research in a Medical Affairs environment highly desired and preferred. Experience in oncology desired Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Director, GMA Oncology, Clinical Operations City Basking Ridge Functional Area Global Medical Affairs Oncology State New Jersey

About the JobThe Associate Director, Quality Engineering is a hands-on leader for the Professional Services pillar of the Quality Engineering team comprising of System Integration Testers, Senior Software Engineers in Test and Performance Testers. This leader leverages advanced Quality Engineering skills while mentoring individual contributors and collaborating cross functionally to drive Quality Engineering initiatives. In addition to managing a team, the Associate Director is responsible for building and scaling out core quality engineering disciplines such as performance testing, security testing, compliance testing, reliability and scalability testing. The Associate Director also oversees all levels of quality checks performed, performs gap analysis across the enterprise, builds the vision for the professional services team and executes on that vision. This position defines practices, procedures, methodologies, and tools to be used in a Test-Driven Development and Data Driven Testing Model, which is compliant by design. This leader oversees a team that is responsible for the development and execution of test plans against custom reference system software to verify that the final product conforms to the original design criterion, meets established requirements, and is free from defects. The Associate Director strategically leads the entire team towards the 100% automated test execution and embedded testability requirements within the Engineering cycles. Key Responsibilities• Oversee the Quality Engineering - Professional Services team comprising of Quality Engineers, Sr Software Engineer in Tests and Performance testers, providing coaching, guidance, direction, evaluation and hiring as needed.• Track deliverables, direct workflows and prioritize for the team.• Generate the overall operational procedures for quality engineering to be used by the team, cross team and department.• Align internally with Tools & Platforms and Compliance Engineering teams to design procedures which are compliant and testable by design with a focus on complete automation.• Build and scale out core quality engineering disciplines such as performance testing, security testing, compliance testing, reliability and scalability testing.• Manage and help define environment strategy across the Enterprise needed for the different levels of testing for the teams.• Manage, provide guidance to and monitor performance of contract testing teams.• Conform to all elements within the FMI Software Development Lifecycle.• Validate quality processes by:· Establishing product specifications and quality attributes;· Measuring production;· Documenting evidence;· Determining operational and performance qualifications; and,· Writing and updating quality assurance procedures.• Develop, in close collaboration with other teams, the change control process for software releases.• Continue to evolve and mature existing Quality Engineering Standard Operation Procedures.• Interact with the development and product staff in order to identify and resolve issues in a timely efficient manner.• Other duties as assigned.QualificationsBasic Qualifications• Bachelor's Degree in a relevant field• 8+ years of professional software programming experience• 2+ years of experience managing direct reports• Proficiency in Java or PythonPreferred Qualifications• Master's Degree in Engineering, Computer Science, Software Engineering, MIS, or similar discipline• 10+ years of experience with automated software testing tools and practices• 5+ years of experience in Performance and Security testing• Prior experience with designing standard operating procedures and rolling out across the Enterprise• Prior experience in working in both a centralized and federated model of the department• Prior hands on experience with Cloud and DevOps tools and technologies• Prior experience with a structured software language• Understanding of HIPAA and importance of privacy of patient data• Commitment to FMI values: patients, innovation, collaboration, and passion

Radius Health Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to . Click here to navigate to the EEO is the Law poster. Click here to navigate Radius Health's Pay Transparency Policy. Executive Director, Head of Quality Assurance US-PA-Wayne | US-MA-Waltham Job ID: 2 Type: Regular Full-Time # of Openings: 1 Category: Quality - Dept Overview Radius is a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases. Radius is committed to the research and development of new therapeutics for the large and underserved osteoporosis market. The Company currently has one commercial product as well as abaloparatide in development in transdermal (Abaloparatide-TD) methods of administration for the potential prevention of fractures in post-menopausal women at risk of fracture from osteoporosis. The Exec Director, Head of Quality is responsible for oversight of all GxP activities at Radius Health. This includes GMP, GCP, GLP, GVP and associated Quality Systems. This position is also responsible for continuous process improvements in the quality area. Responsibilities GMP Oversight and compliance to all relevant local requirements of all product through the product lifecycle from development to commercialization: Ensures that appropriate equipment, lab computer systems, and method validation are complete. Promotes recognition of quality programs among internal and external customers. Oversees CMO QA activities of multiple functional areas and manufacturing sites, ensuring consistent application of cGMPs; QSR; ISO 13485, ICH, and other relevant regulations and guidance. Organizes internal investigations and assures complete and accurate documentation. Reviews and approves documents as required, including protocols, reports, document changes, etc. Manages and supports GMP Quality Management Systems. Responsible for batch review / batch disposition. Oversees Product Complaints. Conducts investigations into GMP-related issues and manages QA change control process. Supports activities for the R&D departments including, review of draft and executed batch records, release of pharmaceutical products and QA review and approval of product label proofs. Oversight of GCP, GLP and GVP QA, including but not limited to oversight of the following activities: Maintaining appropriate knowledge, expertise and global experience in the principles and applications of related ICH guidelines Vendor, clinical trial site (for GCP) and internal audit planning, conduct, reporting and management of related findings, investigations and CAPAs Procedure development Identification and monitoring of deviations, investigations and CAPAs Inspection Readiness Oversight of Radius GxP Quality Management System: Controlled Documents: (i.e. policies, Standard Operating Procedures (SOPs), Work Instructions (WIs), Templates and Forms) Training Management System including the establishment and maintenance of appropriate training curriculum, assignment, records management and compliance monitoring and reporting Oversee selection and fully-validated implementation of a QMS, including authoring, review, approval and tracking of GxP Deviations, Product Complaints, GxP Audits (and their related CAPAs, Investigations and Findings) and GMP Change Control. Refine functionality and ease of use of the QMS to meet evolving needs of GMP QA and GCP/GLP QA, as well as Computer Systems Validation QA. Oversight of Document Management at Radius Health to ensure compliance with regulatory requirements and corporate SOPs: Liaises with Information Technology (IT) to maintain functional requirements for all GxP Quality Systems Establish and refine corporate Computer Systems Validation (CSV) procedures, organization and oversight to ensure adherence to 21 CFR Part 11 regulations within Radius Health and any external vendors and partners Liaises with Functional Area Leads to identify and design document management procedures that are compliant and integrated into organizational EDMS (and/or, when relevant, paper archives). Identify, define and lead implementation of proactive, cross-organizational process improvement and change initiatives to establish and sustain an effective and efficient operational environment across regulated R&D, GMP manufacturing, pharmacovigilance and medical affairs functional areas. Qualifications Bachelor's degree in scientific discipline required, advance degrees preferred Solid understanding of quality management and continuous process improvement principles including global cGMP requirements, ISO 13485, ICH and other relevant regulations is required Deep understanding of GCP, GLP and GVP regulations, guidances and principles is required Experience in Technology Transfer, Scale up and late phase clinical development. Experience with PAI and NDA preparation and inspection readiness Understand R&D Development activities in bio pharmaceutical 15+ years of relevant GMP/GCP/GXP experience Ability to lead quality professionals Have the ability to maintain attention to detail while executing multiple tasks. Work Environment While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. PM18 PI

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. JOB SUMMARY The Senior Director of Global Quality Engineering is responsible for the development and application of harmonized global Quality standards and guidance required for GxP facility and equipment capital projects across the Emergent network. This role will assure facility and equipment designs meet GxP requirements for operations, e.g., material and personnel flow, while addressing both internal and external stakeholder needs. He/She will hire and lead the appropriate Quality commissioning and validation resources to achieve qualification and licensing of equipment and facilities per defined schedules. This role will also collaborate with internal and external regulatory partners to support timely regulatory agency submissions and approvals. This role will lead teams across the network in an integrated way to support the delivery of business unit goals. He/She will be responsible facilities and equipment accommodate a multi-product, multi-host environment and must be skilled in the design and execution of segregation and changeover controls between hosts and platforms. ESSENTIAL FUNCTIONS Define standards and align Quality approach for facility and equipment design and qualification across the network Partner with BU representatives to assure an appropriate level of Quality support for capital projects Project management for all Quality aspects of facility and equipment capital projects Manage staff to qualify, validate, and commission equipment and facilities Includes CSV and Data Integrity plans Represent Emergent to both internal and external contract partners and Regulatory bodies for capital improvement projects Write and review regulatory submission documents in support of capital project approvals Provide leadership and strategic direction to the specified Quality and cross-functional teams Develop staff to enhance capacity and establish Emergent as a thought leader in biopharmaceutical manufacturing Ensure the proper interface of the quality function to product development, manufacturing, engineering/maintenance, and other areas as required Establish strong relationships with internal and external customers-to build, enhance and ensure quality awareness. Collaborate with all departments to ensure that quality standards and GxP compliance are met and maintained. Develop and monitor appropriate metrics to track quality and process improvement. Develop the required site processes and competencies to ensure that quality standards are implemented in accordance with corporate goals. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS BS degree in (Biological) Science, Engineering, or Operations Management; Advanced Degree (s) preferred Position requires a seasoned Quality professional with a minimum of 15 years of experience in biopharmaceutical/vaccine companies Must have a track record of success and a broad understanding of contemporary Quality and Manufacturing practices as they apply to GxP facility, equipment, and process design, execution, and improvement Experience in a multi-product, multi-host environment and will need to be skilled in the design and execution of segregation and changeover controls between hosts and platforms Should have an excellent understanding of Quality requirements in both the US and EU Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance. Significant experience and knowledge in Quality areas (Quality Assurance & Quality Engineering) including Validation and Data Integrity Proven expertise in the design and implementation of Quality processes in a world-class medical device/pharmaceutical/vaccine manufacturing organization Ability to effectively relate the Quality Engineering function to the business as a whole. Excellent verbal & written communication skills PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Raleigh General Hospital Under the supervision of an RN, assists in assuring optimal patient care. Provides direct patient care Performs specific documentation in the patient's recordMaintains equipment and supplies and participates in quality assuranceCommunicates appropriate information intradepartmentally and iterdepartmentallyAssists and participates in staff education and pursues continuing education for personal development. Applies knowledge of age-related factors appropriately to patients, utilizing appropriate policies and procedures Reports to: Department Director FLSA: Non-exempt Grade: N03 Job Requirements: Minimum Education High school diploma or equivalent - Preferred Required SkillsRequires critical thinking skills, decisive judgment and the ability to work with minimal supervision. Must be able to work in a stressful environment and take appropriate action.Certifications: Nursing Assistant Certificate PreferredBasic Life Support (BLS) - to be obtained within 30 days.Minimum Work ExperiencePrevious relevant experience or completion of base skills as a registered nursing student. Equal opportunity and affirmative action employers and are looking for diversity in candidates for employment: Minority/Female/Disabled/Protected Veteran

Los Alamos Medical Center This combined position holds responsibilitiesas the Blood Bank MT Lead and department Resource Tech. Follows standardized proceduresand helps prepare sample for testing. Collectssamples and analyze bodily fluids and substances for abnormalities. Collectsblood and study blood samples used in transfusions. Operates laboratory equipment in ahigh-quality, effective manner. Analyzestest results for accuracy, acceptability, and critical limits, andreports/documents results per organization standards. Performs automated tests using computerizedinstruments and automated equipment. Performsmanual tests based on detailed instructions from a physician. Runs tests andanalyzes the results to be reported to the patient, physician or registerednurse. Performs Quality Assurance workto ensure accuracy of equipment. Monitors the technical functions of the labdepartment including equipment safety, validity of the test results andevaluation of problems identified, correlation studies, review and revision oftest procedures and methodologies, document of quality control practices,inventory management and employee orientation. Oversees day to dayactivities and assists the Director with Human Resources management issues inthe laboratory department. Monitors Proficiency Testing activitiesincluding reviewing results and documenting corrective action asrequired. Assists the Director in supervising staff including: Medical Technologist, MLTs, Lab Assistant and clerical personnel. Performs common testing procedures and reports testing results. Performsinstrument maintenance and troubleshooting. Performs quality controltesting. Maintains supplies needed for performance of tests. Maytemporarily take over several supervisor responsibilities of the Lab in theabsence of the Director. Assists Director in KRONOS timekeeping editingfor the department. Assists Director in scheduling responsibilities forthe departments. Job Requirements: License/Certifications: ASCP or AMT Certification as MT or Equivalent Required Basic Phlebotomy skills are required BLS must be obtained within ninety (90) days from hire. New hires will have ninety (90) days from date of hire to obtain American heart Association certifications. Notwithstanding the 'grace period' for obtaining American Heart Association certification, employees are not excused from being current in any and all existing certifications that are required for their position as outlined in the position job description. Requires critical thinking skills, decisive judgement and the ability to work with minimal supervision. Must be able to work in a stressful environment ant take appropriate action. Minimum of three years of previous leadership experience preferred. Equal opportunity and affirmative action employers and are looking for diversity in candidates for employment: Minority/Female/Disabled/Protected Veteran

In this role, you will have the opportunity to work independently and collaboratively in an exciting young company. Overall Description: The Clinical Research Associate (CRA) will provide clinical study support for one or more clinical studies/programs, ensuring efficient delivery of clinical trials in a matrix environment. Key accountabilities include assuring successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures, as well as supporting clinical project timelines, contracts, budgets, vendor management, invoicing, accruals, oversight monitoring, meeting milestones and deliverables, and internal/external communications. Remote-based is optional depending on prior experience. This is an in-house (limited travel) position and will report to the Director/Associate Director, Clinical Operations. Job Duties and Responsibilities: Responsibilities may include, but are not limited to: Obtains and reviews all required essential documents necessary for study/site initiation Maintains accurate and timely sponsor/site correspondence and communication. Prepares and presents project progress reports Ensure studies are managed and executed in accordance with ICH GCP, regulations, the protocol and company SOPs Supports and may lead the development and review of clinical study plans, presentations or study-related documents Supports in the development and design of CRFs, including participating in the EDC and IWRS specification process and UAT Assists with set-up of central labs and study vendors as required, including liaising with Project/Program Manager and CRO to ensure site training and timely initiation Performs in-house review of clinical data listings for completeness and accuracy and escalate issues to the Project/Program Manager, as needed Manages clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics May perform accompanied site visits with CRO CRAs to ensure correct study procedures according to SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and study plans, as required Reviews monitoring trip reports and track resolution of all action items Participates in the selection, training, and evaluation of study personnel (vendor, CRO, internal) Assists with providing oversight of CROs and vendors including managing cross-functional teams Responsible for oversight and mentoring of junior team members Collaborates with internal cross functional teams to ensure effective delivery of the assigned project milestones Organizes and manages internal team meetings, investigator meetings, and other trial specific meetings, as requested Provides support in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments, as applicable May visit sites (in conjunction with CRO, if applicable) for oversight, site evaluation, initiation, monitoring, or close-out activities Participate and respond to Quality Assurance and regulatory authority inspection audits Recommends and implements innovative ideas to increase efficiency and quality of project/program management activities Qualifications : Bachelor's degree, preferably in a scientific field Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent, at a minimum of 2 years Demonstrates core understanding of medical terminology and clinical trial activities Skills/Abilities: Thorough understanding of ICH GCP guidelines Understanding of clinical trial processes from study start-up through study closure Ability to establish priorities, sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors Self-motivated, assertive and able to function independently or as part of a team Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners) Proven problem solving and decision making skills Ability and willingness to travel 10-20% (domestic and international)

SUMMARY: The Quality Assurance Internal Auditor is responsible for conducting and augmenting internal audit activities of assigned SNC Operations, Engineering and Programs at various SNC locations and assist in providing oversight and continual improvement to SNC's Enterprise QMS system. These internal auditing activities are used to assess and ensure quality assurance compliance, both internally and externally per the requirements of ISO 9001:2008 and AS9100 Quality Requirements. At SNC's Integrated Mission Systems (IMS) team we are an agile, high-caliber contractor that engineers, builds, integrates, modifies and supports turnkey air- and ground-based Intelligence, Surveillance, and Reconnaissance (ISR) products and services. Our years of experience supporting the Department of Defense, Department of Homeland Security, commercial and international customers have established us as the systems integrator of choice. We take great pride in the customer mission we support. Learn more about IMS SUMMARY: The Auditor is responsible for leading and conducting audits to insure that all management and employees throughout the Enterprise are in conformance to the company Quality Management System and high work standards to ensure that all activities meet or exceed all business goals, customer/industry/regulatory requirements and SNC process and procedures. Auditing & Compliance - Schedule and conduct internal quality assurance compliance and special process audits of all SNC locations assigned to him/her and participate in external (Registrar, Customer) audits when requested to ensure internal, customer, industry and/or regulatory requirements are being met. SNC's Quality Assurance Internal Auditors will be cross trained to ensure that all special process work performed at any SNC facility is being performed properly (i.e.: Engineering design operations, airframe modifications, space systems production, etc). Auditor will be responsible for documenting and preparation of quality reporting, tracking of open audit findings, reviewing and approving of internal audit responses to ensure appropriate actions are taken to resolve quality deficiencies. Auditor will assist locations in the development of corrective and preventive action plans and conduct follow up audits when required. Communication - Establish clear communication within and between SNC's network to ensure consistency in what is expected related to training and Product/Quality Assurance requirements. Customer Relations - When required assist in investigations of external and internal nonconformances and prepare investigation reports for management. Delegate / Support - Use effective delegation skills within work teams that support the overall business / operational and Product/Quality Assurance goals, i.e. aiding locations with QA processes to insure that they can maintain compliance after the audit is over. Establish and monitor project completion deadlines as necessary to meet our overall company goals, i.e. monitoring audit response information. Financial Accountability - Manage travel costs and continuous working with other department personnel to achieve an orderly approach to developing an audit schedule that divides areas of the country that achieves the best use our auditing personnel's time. Problem Resolution - Pro-actively apply problem solving skills to a) clearly identify the problem; b) use data / facts to determine governing requirement for the investigation of root cause so that the locations can make the proper corrective action. Quality - Enforcement of SNC's quality standards and requirements on all work that is performed. Enforce and help all levels of SNC employees recognize quality as a key element of customer satisfaction and meeting SNC's business goals. Insist that everyone be expected to demonstrate the highest work ethics when performing job functions, in dealings with their fellow employees, supervisors or outside customers, auditors or regulatory bodies. Ensure that Product/Quality Assurance training has been given to all employees so that they fully understand what their role in quality is and how it pertains to them. Reporting Requirements - Send all Internal Audit reports to management as required per SNC's Audit Procedures. Track and approve Internal Audit replies. Directly reports to Corporate Director of Product Assurance and Safety. Training - Aid in establishing SNC process needs and assist in developing SNC's written processes and procedures necessary to ensure that all employees in work center and departments have the necessary training and instructions to perform their duties to meet SNC, customer, industry and regulatory requirements. Must Haves: Requires a BA/BS in Related Field. Relevant work experience may substitute for required education. Excellent communications skills, both written and verbal. Knowledge and utilization of AS9100, ISO 9001 and other applicable Military and statutory Standards and Specifications. Strong computer skills are required with good working knowledge of MS Office Suite. Ability to work independently and make appropriate decisions. Working in a Quality Management System in understanding, following and enforcing compliance as an Auditor. Aid and develop all work processes to ensure all employees meet or exceed customer, SNC, industry or regulatory requirements. Successfully completes all required training by the Corporate Director of Product Assurance and Safety that relate to the duties of this job. Acceptable Courses: Certified or nationally recognized Auditor Training Course, AAR Auditors Training Course, ASQ Quality Auditor Training course. Three to five years experience working with a Quality Management Program. These experiences should be gained in areas of Auditing and or Management Position. IMPORTANT NOTICE: This position requires the ability to obtain and maintain a Secret U.S. Security Clearance. U.S. Citizenship status is required as this position needs an active U.S. Security Clearance for employment. Non-US citizens may not be eligible to obtain a security clearance. The Department of Defense Consolidated Adjudications Facility (DoD CAF), a federal government agency, handles the adjudicative aspects of the security clearance eligibility process for industry applicants. Adjudicative factors which affect the outcome of the eligibility determination include, but are not limited to, allegiance to the US, foreign influence, foreign preference, criminal conduct, security violations and illegal drug use. At Sierra Nevada Corporation (SNC) we deliver customer-focused technology and best-of-breed integrations in the aerospace and defense sectors. SNC has been honored as one of the most innovative U.S. companies in space, a Tier One Superior Supplier for the U.S. Air Force, and as one of America's fastest-growing companies. Learn more about SNC Sierra Nevada Corporation is an Equal Opportunity Employer - Minority / Female / Disability / Veteran, or any other protected status pursuant to applicable local, state or federal law, ordinance or regulation.

Minimum Required Skills: 150-300 Unit Multifamily Projects, Owner/Builder Experience, Ground-Up High-Density Multifamily Jobs, Wood Framing, Podium & Wrap Style Jobs If you are a Multifamily Sr. Project Engineer with experience, please read on! Based out of Pasadena, CA, our company is a trusted real estate and construction adviser to Fortune 500, mid-size and start-up companies. We are a leader in the Western United States, but maintain our strongest presence as one of Southern California's largest and most respected builders. We have successfully developed millions of square feet of space across virtually every real estate sector. We take great pride in these buildings, but find even greater accomplishment in the respect, integrity and relationships we've built along the way. What You Will Be Doing Summary of Position Requirements - Provide leadership for all on-site personnel and to manage all aspects of the pre-construction and construction of each assigned project. - Director of Construction is responsible for support and supervision of all on-site construction and land development, including budget, scheduling, quality assurance and safety on the job site and to ensure compliance with plans, specifications and relevant building codes. - Directly supervise the activities of the Superintendent. Principal Duties and Responsibilities Pre-Construction: - Provide construction input to design professionals - Pre-development input of construction techniques and cost. - Provide oversight for value engineering for all pre-development projects. - Establishment of all final construction documents, schedules, and budgets. - Manage options list and provide coordination and accurate pricing of each. - Assist estimating department with providing qualified trades for the bidding process. - Coordinate with plans, specs, and bids to finalize subcontractor scopes. - Manage compilation of provided GMP documents. Course of Construction: - Responsible for individual projects from start to finish. - Oversee the preparation of weekly monthly reports on project progress. - Organize and run project meetings. - Regularly update the project schedule with Project Manager. - Manage subcontractor change orders. - Review and approve entire subcontractor's and supplier's pay request. - Analyze job costs and manage the project to the closing budget. - Help Project Managers resolve issues on project level. - Log and distribute new project documentation. - Resolve subcontractor disputes - Provide documentation and direct Contract Manager in compiling subcontracts and purchase orders. - Oversee project setup. - Provide assistance to Vice President in all legal matters related to assigned projects. - Directly supervise the activities of the Project Manager, Contracts Manager, and Project Engineer. - Oversight on a day to day of all on-site construction activities. - Evaluate performance of project team members. - Ensure project and subs are in compliance with company safety standards. - Promote safety on assigned projects and evaluate subcontractor's work to monitor compliance with company safety standards. Post-Construction: - Completion and close-out of the project and the acceptance of each project by the Owner. - Address the warranty issues and complete final documentation. Other: - Directly supervise the activities of the Project Manager. - Assist Safety Director by representing the Company on OSHA inspections when necessary. - Provide Safety Director with reports on projects when necessary. What You Need for this Position Must have skills: - 1 - 3 plus years of Project Management experience within the Ground-Up Multifamily space - 1 - 3 plus years years of General Contracting / Owner-Builder Experience - Recent Ground-Up Multifamily Construction experience - Wrap Style Building experience - Type-III Wood Framing on Multifamily Structures experience Skills: - Must be familiar with multi-family general contracting procedures. - Knowledge of construction building codes. - Ability to communicate verbally and in writing. - Knowledge of construction estimating and scheduling practices. - Must demonstrate managerial skills appropriate with this position. - Must be PC proficient. - Experience waiver: Management reserves the right to amend, modify or waive any education, experience or skill requirement for this position. Software Skills: - Procore - Emails - Bidding - Budget - Change Orders - RFI's - Meetings - Schedule - Reports - Drawings - Documents - Microsoft Office: MS Project, MS Word, MS Excel - Acrobat What's In It for You We are willing to offer excellent compensation projects including: - Competitive base salary (DOE) - Strong bonus structure - Benefits - Gas and Cell Allowance - PTO Sick Leave - 401(k) retirement plan - And more...So, if you are a Multifamily Sr. Project Engineer with experience, please apply today! Applicants must be authorized to work in the U.S.Please apply directly to by clicking 'Click Here to Apply' with your Word resume! Looking forward to receiving your resume and going over the position in more detail with you. - Not a fit for this position? Click the link at the bottom of this email to search all of our open positions. Looking forward to receiving your resume! CyberCoders CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Copyright 1999 - 2020 . CyberCoders, Inc. All rights reserved. - provided by Dice