7 jobs found

Department RESEARCH COMPLIANCE (UA-RCIN-IUBLA) Department Information Indiana University is one of the top research universities in the world, with over $785 million in sponsored research last fiscal year. Growing transformative research and creativity, innovation, industry engagement, and commercialization are key goals in IU 2030: The Indiana University Strategic Plan. The AVP for Research Compliance is a member of the Vice President for Research's senior leadership cabinet, which includes the IU School of Medicine Executive Associate Dean of Research Affairs. Job Summary Reporting to the Indiana University Vice President for Research, the Associate Vice President (AVP) for Research Compliance (ORC) oversees 6 primary compliance functions university-wide (see below). ORC ensures service provision, including oversight of research compliance management systems, on all IU campuses university-wide, including IU Bloomington, IU Indianapolis, the School of Medicine, and 5 regional campuses located in Gary, Kokomo, New Albany, Richmond, and South Bend. Department-Specific Responsibilities Responsible for the infrastructure and procedures that enable researchers on all IU campuses to remain in compliance with all applicable state and federal laws, as well as university policies. Collaborates closely with research leadership at the School of Medicine, other IU Research senior leaders, other relevant leaders across the university, and with key external partners. Provides high-level oversight of administrative offices and committees hat review thousands of studies or cases per year, and ensures policies and processes reflect the current regulatory environment, including but not limited to ensuring preparation for regulatory changes. Ensures staff are knowledgeable, service-oriented, and appropriately resourced. Engages with internal and external partners and stakeholders and will work to steward collaborative relationships with the IU research community, federal agencies, and accreditation bodies. The AVP has 7 director-level direct reports. The ORC team includes approximately 70 Full-Time Employees and the following organizational divisions and associated functions, as well as oversight of compliance management systems. Ensures the rights, welfare, safety, and consent of people who act as subjects in research projects. Upholds requirements for using animals in research, testing, or teaching. Provides oversight for IU's Institutional Biosafety Committees to review each protocol to ensure research is conducted with attention to the safety of laboratory personnel, the environment in which the research is conducted, and the community at large. Ensures oversight and safe use of radiation and radioactive materials that are potentially hazardous to human health working in collaboration with colleagues in IU Environmental Health and Safety. Documents and mitigates real or perceived issues when outside financial interests may overlap or conflict with a researcher's activities. Promotes integrity in research through education and adjudicating and addressing research misconduct. Provides leadership and operational oversight and continuous improvement of institutional compliance. Oversees continual quality improvement for ORC functions, ensuring ongoing implementation of best practices, providing strategic and integrative leadership to all units of ORC. This includes guaranteeing that each function, and associated compliance management systems, are not only delivering required compliance infrastructure but have workflow and procedures, providing quality assurance of service provision, required documentation, and user satisfaction. Ensures ongoing, streamlined compliance support to meet the broad research needs of IU's faculty, research staff and administrative units to ensure compliance while maximizing use of available resources and advocating for additional resources if/when needed. Establishes an integrated culture of compliance within the University and with external partners and stakeholders. Works with researchers across IU to foster a culture of strict ethical conduct of research and strong institutional compliance, including representing IU in communications with federal agencies. These communications include but are not limited to: answering questions; drafting and finalizing reports as required; collaborating on developing corrective action plans if needed; and providing comments on regulatory matters when requested or appropriate. Fosters a positive working relationship with faculty to build a culture of support. Responsible for building strong relationships with the leadership of accreditation bodies, professional organizations, and academic organizations, nationally and internationally, and serves as a resource when called upon for presentations, advice, or consultation by such organizations. Collaborates closely with the IU School of Medicine, all members of the IU Research Senior Leadership Team and support the Vice President for Research, while working alongside IU shared services partners to meet Office of Research Compliance needs on behalf of the researchers served. IU shared service partners include finance, HR, IT and communications and marketing. Qualifications EDUCATION Required Master's degree Preferred Ph.D., M.D., JD degree, or other relevant terminal degree including Pharm.D. WORK EXPERIENCE Required Demonstrated national experience as a research compliance thought leader Demonstrated experience with faculty or scientist training and mentoring programs Experience as a director or senior-level compliance administrator at a major research university, and preferably one with a medical school SKILLS Required Strategic and operational accountability for institutional compliance, ensuring each Office for Research Compliance (ORC) unit operates with integrity and efficiency and has ongoing programs for quality review and improvement Working Conditions / Demands This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment, the campus, and travel. The person in this role must be able to perform the essential functions with or without an accommodation Additional Information This is an open, national, and rolling search. Review of applications will begin immediately as they are received. Candidates meeting all the required qualifications may be contacted immediately for inquiry and interview. Work Location IU Indianapolis Campus or IU Bloomington Campus This position is eligible to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs. Benefits Overview For full-time staff employees, Indiana University offers a wide array of benefits including: Multiple plan options for medical insurance Dental insurance Health Savings Account with generous IU contribution Life insurance, LTD, and AD&D options Base retirement plan contribution from IU, subject to vesting Additional supplemental retirement plan options Tuition benefit for IU classes 10 paid holidays per year Generous Paid Time Off Paid Parental Leave Employee Assistance Program (EAP) Learn more about our benefits by reviewing our online Benefits Brochure. Job Classification Career Level: Senior Executive FLSA: Exempt Job Function: Research Job Family: Research Compliance Click here to learn more about Indiana University's Job Framework. Posting Disclaimer This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date. If you wish to include a cover letter, you may include it with your resume when uploading attachments. Equal Employment Opportunity Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information. Campus Safety and Security The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at or by visiting IUPD. Contact Us . click apply for full job details

Department RESEARCH COMPLIANCE (UA-RCIN-IUBLA) Department Information Indiana University is one of the top research universities in the world, with over $785 million in sponsored research last fiscal year. Growing transformative research and creativity, innovation, industry engagement, and commercialization are key goals in IU 2030: The Indiana University Strategic Plan. The AVP for Research Compliance is a member of the Vice President for Research's senior leadership cabinet, which includes the IU School of Medicine Executive Associate Dean of Research Affairs. Job Summary Reporting to the Indiana University Vice President for Research, the Associate Vice President (AVP) for Research Compliance (ORC) oversees 6 primary compliance functions university-wide (see below). ORC ensures service provision, including oversight of research compliance management systems, on all IU campuses university-wide, including IU Bloomington, IU Indianapolis, the School of Medicine, and 5 regional campuses located in Gary, Kokomo, New Albany, Richmond, and South Bend. Department-Specific Responsibilities Responsible for the infrastructure and procedures that enable researchers on all IU campuses to remain in compliance with all applicable state and federal laws, as well as university policies. Collaborates closely with research leadership at the School of Medicine, other IU Research senior leaders, other relevant leaders across the university, and with key external partners. Provides high-level oversight of administrative offices and committees hat review thousands of studies or cases per year, and ensures policies and processes reflect the current regulatory environment, including but not limited to ensuring preparation for regulatory changes. Ensures staff are knowledgeable, service-oriented, and appropriately resourced. Engages with internal and external partners and stakeholders and will work to steward collaborative relationships with the IU research community, federal agencies, and accreditation bodies. The AVP has 7 director-level direct reports. The ORC team includes approximately 70 Full-Time Employees and the following organizational divisions and associated functions, as well as oversight of compliance management systems. Ensures the rights, welfare, safety, and consent of people who act as subjects in research projects. Upholds requirements for using animals in research, testing, or teaching. Provides oversight for IU's Institutional Biosafety Committees to review each protocol to ensure research is conducted with attention to the safety of laboratory personnel, the environment in which the research is conducted, and the community at large. Ensures oversight and safe use of radiation and radioactive materials that are potentially hazardous to human health working in collaboration with colleagues in IU Environmental Health and Safety. Documents and mitigates real or perceived issues when outside financial interests may overlap or conflict with a researcher's activities. Promotes integrity in research through education and adjudicating and addressing research misconduct. Provides leadership and operational oversight and continuous improvement of institutional compliance. Oversees continual quality improvement for ORC functions, ensuring ongoing implementation of best practices, providing strategic and integrative leadership to all units of ORC. This includes guaranteeing that each function, and associated compliance management systems, are not only delivering required compliance infrastructure but have workflow and procedures, providing quality assurance of service provision, required documentation, and user satisfaction. Ensures ongoing, streamlined compliance support to meet the broad research needs of IU's faculty, research staff and administrative units to ensure compliance while maximizing use of available resources and advocating for additional resources if/when needed. Establishes an integrated culture of compliance within the University and with external partners and stakeholders. Works with researchers across IU to foster a culture of strict ethical conduct of research and strong institutional compliance, including representing IU in communications with federal agencies. These communications include but are not limited to: answering questions; drafting and finalizing reports as required; collaborating on developing corrective action plans if needed; and providing comments on regulatory matters when requested or appropriate. Fosters a positive working relationship with faculty to build a culture of support. Responsible for building strong relationships with the leadership of accreditation bodies, professional organizations, and academic organizations, nationally and internationally, and serves as a resource when called upon for presentations, advice, or consultation by such organizations. Collaborates closely with the IU School of Medicine, all members of the IU Research Senior Leadership Team and support the Vice President for Research, while working alongside IU shared services partners to meet Office of Research Compliance needs on behalf of the researchers served. IU shared service partners include finance, HR, IT and communications and marketing. Qualifications EDUCATION Required Master's degree Preferred Ph.D., M.D., JD degree, or other relevant terminal degree including Pharm.D. WORK EXPERIENCE Required Demonstrated national experience as a research compliance thought leader Demonstrated experience with faculty or scientist training and mentoring programs Experience as a director or senior-level compliance administrator at a major research university, and preferably one with a medical school SKILLS Required Strategic and operational accountability for institutional compliance, ensuring each Office for Research Compliance (ORC) unit operates with integrity and efficiency and has ongoing programs for quality review and improvement Working Conditions / Demands This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment, the campus, and travel. The person in this role must be able to perform the essential functions with or without an accommodation Additional Information This is an open, national, and rolling search. Review of applications will begin immediately as they are received. Candidates meeting all the required qualifications may be contacted immediately for inquiry and interview. Work Location IU Indianapolis Campus or IU Bloomington Campus This position is eligible to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs. Benefits Overview For full-time staff employees, Indiana University offers a wide array of benefits including: Multiple plan options for medical insurance Dental insurance Health Savings Account with generous IU contribution Life insurance, LTD, and AD&D options Base retirement plan contribution from IU, subject to vesting Additional supplemental retirement plan options Tuition benefit for IU classes 10 paid holidays per year Generous Paid Time Off Paid Parental Leave Employee Assistance Program (EAP) Learn more about our benefits by reviewing our online Benefits Brochure. Job Classification Career Level: Senior Executive FLSA: Exempt Job Function: Research Job Family: Research Compliance Click here to learn more about Indiana University's Job Framework. Posting Disclaimer This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date. If you wish to include a cover letter, you may include it with your resume when uploading attachments. Equal Employment Opportunity Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information. Campus Safety and Security The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at or by visiting IUPD. Contact Us . click apply for full job details

By joining our team, you'll be part of our life-changing Mission and Vision. You'll work in a truly inclusive environment where diversity and equity are championed through words and actions. You'll contribute to an innovative culture that is second to none, one that embraces curiosity, discovery and compassion. You'll play a role in something that's never been done before as we integrate science and clinical care to help patients achieve better, faster outcomes - as we Advance Human Ability, together. Job Description Summary Processes all applications from physicians for: 1. Medical staff appointment, clinical privileges and/or reappointment to the SRALAB Medical Staff, including primary source verification 2. Managed care credentialing with companies who contract with SRALAB. 3. Medicare/ Medicaid/IDPH provider numbers (for physicians, nurse practitioners and select allied health staff). Consistently demonstrates support of the SRALAB Statement of Mission and Philosophy by striving for excellence, contributing to the team efforts and showing respect and compassion for patients and their families, fellow employees, and all others with whom there is contact at or in the interest of the Institute. Job Description Distribute applications upon request and establish electronic database file for medical staff members Upon return of application, check for completeness and all required documentation. Analyze information for discrepancy, misstatement, missing data, and time gaps. Enter data into electronic database file. Establish checklist for monitoring and tracking documents in credentials file. Perform primary source verification of information contained in application. This includes on-line electronic/internet sources such as the National Practitioner Data Bank, Office of the Inspector General, and the Illinois Department of Professional Regulations. Analyze credentialing information obtained for compliance with medical staff criteria and qualifications. Discuss key issues and problems to the Credentials Committee and the Senior VP for Medical Affairs. Give completed application to Senior VP for Medical Affairs for his review. Send copies of completed applications to Credentials Committee for review prior to meeting date. Prepare Minutes of meeting for presentation to Medical Executive Committee. Maintain accurate and current credentialing database for medical staff members. Monitor physicians' license and insurance expirations having potential high-risk exposure for SRALAB. Work with physicians to obtain current documentation. Acts as liaison person for managed care credentialing. Processes applications for Medicare/Medicaid/IDPH provider numbers for physicians, nurse practitioners and selected allied health staff members. Collects dues from Active Medical Staff and prepares quarterly treasurer's reports. Assures compliance with accreditation standards (JCAHO/CARF) and regulatory guidelines (state, federal) including Medical Staff Bylaws and policies/procedures. Maintains good working relationship between the SRALAB Medical Staff Office and the other Medical Staff Offices of the McGaw Medical Center (Children's Memorial Hospital, Northwestern Memorial Hospital, Evanston Hospital, NUMS. Other Responsibilities: Enters new physician data into the Meditech user directory, and updates same with any change in physician status. Maintains on-line up-to-date listing of Attending and Consulting Physicians. Maintains Physician Privileges Manuals on all nursing and outpatient floors. Works with Senior VP for Medical Affairs to set up new physician orientation. Prepare Physician Orientation Notebooks for all new Attending Physicians. Answers queries from other hospitals on current and former Attending Physicians and Fellows. Reporting Relationships Reports to the Senior VP for Medical Affairs Knowledge, Skills & Abilities Required Work requires secretarial skills normally acquired through six months or less of formal training, plus two years of college. Bachelor's degree preferred. Work requires two to three years of progressively more responsible clesralabal or secretarial experience and the ability to exercise independent judgement. Interpersonal skills needed in order to interact with key managerial personnel within the hospital and peers within the medical community. Excellent analytical ability needed to prepare reports and documents and to maintain various administrative records. Work frequently produces a high level of mental/visual fatigue while preparing reports, correspondences, etc. Work requires proficient computer skills and knowledge of Windows and Word for Windows in order to run credentialing software Working Conditions Normal office environment with little or no exposure to dust or extreme temperature. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Equal Employment Opportunity ShirleyRyan AbilityLab is an equal opportunity/affirmative action employer. All 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.

#RPM Teaching faculty at Guilford Technical Community College are responsible for supporting student success by creating an optimum learning environment, responding to student needs, managing effective instructional activities, developing Emergency Medical Science (EMS) courses, modeling employability skills, demonstrating professionalism, developing cooperative work relationships with other faculty and staff, supporting college administrative requirements, and maintaining competency in their instructional field. He/she will be responsible for quality instruction and for effective participation and interest in the total affairs of the college. The EMS OE Instructor will prepare and teach the non-credit In-Service Training, pre-service EMT training as well as American Heart Association courses and the training in accordance with the requirements of the North Carolina Office of Emergency Medical Science (NCOEMS). This position will support program functions by providing customer service, data support and documentation services. It will also work to maintain program compliance with accreditation standards according to Guilford Technical Community College (GTCC), American Heart Association (AHA), Committee on Accreditation of Educational Programs for the Emergency Medical Services Professions (CoAEMSP), Commission on Accreditation of Allied Health Education Programs (CAHEEP) and Commission on Accreditation for Pre-Hospital Continuing Education (CAPSE). This position reports directly to the Program Director of EMS, with oversight by the Dean of Human Services and Public Safety. Duties/Functions Teaching Prepare & teach departmental courses to include: developing learner centered lesson plans employing teaching strategies & instructional materials for different learning styles incorporating, as pedagogically appropriate, current technology in classroom, distance learning and laboratory environments creating and modeling a quality learning environment that supports a diverse student population preparing, distributing and utilizing instructional support materials, including course syllabi, supplementary materials, instructional media and other devices as appropriate updating and revising curriculum to maintain currency developing new courses as needed to support the instructional mission participating in the development and review of course and program/general education outcomes as appropriate developing, conducting and documenting appropriate assessment of student learning in outcomes courses and programs/general education as appropriate Professional Development Maintain a professional status that supports the instructional mission by: participating in professional development activities to maintain currency in field; maintaining current credentials or licensures as required by program or accreditation participating in professional development opportunities to advance teaching skills and strategies Administration Provide daily & ongoing oversight of facilities, equipment and student records to include: maintaining classroom and laboratory spaces including upkeep of assigned equipment providing for the security of facilities, equipment and instructional materials and maintaining safe working conditions maintaining student records (e.g., grades and attendance) in accordance with established deadlines using a variety of technology-based programs (e.g., Colleague, WebAdvisor, Moodle) complying with all applicable college, state and federal rules and regulations Student Support Provide an environment conducive to student success to include: conducting recruiting activities providing academic advising promoting retention/persistence by assisting students to develop strategies for success assisting students with the registration and graduation process referring students to campus and community resources when appropriate maintain student records College Service Support college-wide endeavors to include: collaboration with faculty and staff from other divisions/departments to promote communication, coordinate schedules and support student success serving on department, division and college committees participating in GTCC institutional initiatives collaborating with educational partners, business/industry and/or external agencies as appropriate to promote the instructional mission of GTCC supporting collegiality and teaching excellence by actively participating in the professional development of new and veteran faculty (e.g., mentoring and peer observation) participating in extracurricular student activities/clubs attending college professional development sessions, college/division/department meetings, graduation and convocation, as required demonstrate and model the Colleges employability skills: adaptability, communication, information processing, problem solving, responsibility and teamwork. perform all duties as assigned by supervisor Difficult Challenges Contacts Education Required Associates degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution North Carolina Paramedic Credential North Carolina Level I Emergency Medical Technician (EMT) Instructor Certification or the ability to obtain it within one year of hire. Valid North Carolina Drivers License Education Preferred Bachelors degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution American Heart Association Basic Life Support (BLS), Advanced Cardiac Life Support (ACLS) and/ or Pediatric Advanced Life Support (PALS) Instructor Certification North Carolina Level I Paramedic Instructor Certification Experience Required Three years of relevant or closely related field experience in Emergency Medical Science (EMS) One year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Experience Preferred Greater than three years of relevant field experience in Emergency Medical Science (EMS) or closely related career field Greater than one year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Post-secondary teaching experience Experience with assessment of student learning outcomes KSA Required The Instructor shall possess an understanding of and commitment to the nature and role of the Community College, particularly its open door policy. He/she shall have demonstrated personal and professional competence for the responsibilities assigned. The Instructor must be able to: 1. Multi-task 2. Respect Diversity 3. Adapt to changing procedures, protocols or assignments. 4. Create and maintain a learner centered environment 5. Communicate effectively 6. Ability to effectively implement and apply technology solutions KSA Preferred Department/Job Specific Requirements Physical Requirements Hear and see Stand extended periods of time (up to 4 hours) Lift up to 50 pounds unassisted. Stoop, bend, squat, lift, reach overhead Use and manipulate EMS equipment according to industry standards Participate in and demonstrate physical aspects of EMS work and physical training The following (compliance) training is required and must be completed within the first 30 days of hire with annual refresher training thereafter: (additional training may be added as needed) Reporting Requirements Anti-Discrimination/Harassment & Title IX Safety/Shooter on Campus Personal Information Protection Training (PIP) Ethics and Social Responsibility eLearning Level One (before the first day of the first semester teaching) eLearning Levels Two and Three for instructors who teach online or hybrid delivery methods (before the first day of the first semester teaching) Physical Demands Physical Activity:Long periods of standing and or walking Environmental Hazard(s):30-70% Lifting:=>50lbs. Criminal history checks with acceptable results, are required. Posting Type Faculty recblid wlec6xqxkvpoxrp5yduinyt3ga15sc

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. Reporting to the Global VP of Supply Chain, this role directs and is responsible for a network of both site and remote functional workstream workers. In support of our matrixed model the role will lead through both solid and dotted line reporting structures. This role will be based out of our Maryland Central Warehouse in Elkridge, MD visiting our MD site network (Bayview, Camden, Rockville) routinely. This matrixed center led role will work closely not only with the network warehousing teams and sites outside of MD, but also directly be responsible for site materials management leaders in MD as a point of contact for the 3 Maryland site leads. It is a key partner, supporter and resource of the site Sr. Leadership teams in MD. This role will assume solid line control of all warehousing activities across all Emergent sites as a horizontal work stream owner. The Sr. Director of Supply Chain role is key to the success of our corporation. Interfacing with internal and external partners to achieve strategic product supply requirements is a must. The successful candidate will ensure that issues regarding new/existing products are resolved in a timely and cost-efficient manner with an assurance of harmonization in practices and system adoption across our network. One of the key requirements for the successful candidate will be a disciplined time management skill set to ensure site success while leading and realizing best demonstrated practices across a specific work stream under management. The role works closely with Fellow Global Supply Chain Peers, Site Manufacturing, Quality, Regulatory Affairs, and Sales Operations in a matrixed reporting environment. Using Operational Excellence principles, develops strategic plans to improve productivity, quality, and efficiency of operations. Delivers on Global Supply Chains core value proposition of Spend Value, Efficiency and De-Risking of the end to end supply chain. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. General Responsibilities: In our Center-led model the candidate will be responsible for oversight management for the three Maryland sites (Bayview, Camden, Rockville). All Production Planning, Procurement and Master Data activities and personnel will report to this role through a dotted line responsibility This role will ensure all Supply Chain work streams operate in accordance with cGMP regulations, and Life Sciences operational BDPs. In our Center-led model this role will assume solid line leadership for all Emergent Warehousing, Inventory Control and Logistics teams across the Emergent network of manufacturing facilities. This role actively works and manages finished goods adhering to serialization requirements as directed in DSCSA & EU FMD. He/She will be an active participant on the Camden Site Leadership Team executing to the site's 5 year growth strategy, and defined SLAs. Role will support / implement the Enterprise's Harmonization initiatives for Supply Chain and other adjacent operations as needed. Responsible for all Transportation and Logistics as required to support the shipment of licensed product as well as other materials including pre-clinical / clinical products, equipment etc. Accountable for Department Cost Center performance. Drive financial performance of business units by pro-actively identifying risks and opportunities in the supply chain and recommending solutions. Developing strategic Plans supported by Capital Expenditure and Operational Expense budgets. Primary liaison for all Contract Manufacturing activities including developmental BOM costing, scheduling, issue resolution, change implementation, performance monitoring and development of teams, etc. Supply Chain Management SME for Regulatory inspections for ongoing Manufacturing Operations and PAI submissions. Facilitate Sales & Operations Planning (S & OP) for 24 month rolling forecast of Manufacturing activities and Delivery expectations as driven by current demand. Maintain, adapt, and implement robust Cold Chain shipping solutions as required. Provide system oversight for Sarbanes Oxley process controls for Supply Chain Management responsibilities. Encourage implementation of Industry Best Practices for Supply Chain activities. Develop and Maintain Master Production Schedule including oversight and adherence to forecast and delivery schedule in preparation to run monthly Operations Meetings and participate in Monthly S&OP processes. Provide support and guidance to site Value Stream Management Committee Maintain business operation procedures and work instructions (process flow diagrams and instructional guides) for critical GSC activities. Develop effective metrics, KPI's and monitoring programs to assure constant vigilance. Maintain collaborative relationships with Manufacturing, Quality, Validation and Facilities Maintenance to assure the complete scope of Planning activities remains connected with other tangential business operations and compliant with Quality requirements. Primary liaison for CDMO business support of contracted products. Culture Management and Leadership Development: Collaborate with Global Supply Chain Peers and Site Leadership Team to build effective teams through common understanding of Company goals, objectives, communication tools and committee structures. Actively support Leadership Development Programs through participation and ensuring participation of area management under scope of responsibility. Integrate Situational Leadership II principles and Performance Management tools throughout Manufacturing Operations Management. Create a culture that achieves employee engagement, efficiency, effectiveness, accountability, customer service, productive work relations and sound communications. Actively drive communication of expectations and tools with respect to critical business activities, including: Job Descriptions, Performance Management (IPMP) plans, Career Ladder expectations, time and project resource allocation management, operational and capital budget management, and targeted career development through succession planning. Compliance: Ensure maximum compliance with current Good Manufacturing Practices, Good Distribution Practices, 49 CFR Dangerous Goods, MiOSHA, OSHA, USDA, and other areas of mandatory regulatory oversight. The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. 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 values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable 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. .buttontextde38d a{ border: 1px solid transparent; } .buttontextde38d a:focus{ border: 1px dashed #c11d4b !important; outline: none !important; }