ASSOCIATE DIRECTOR, QUALITY ASSURANCE (Durham, NC, US, 27710)
School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Job Title: Associate Director, Quality Assurance
Quality Assurance (QA) in a cGMP (current good manufacturing practice) environment is responsible for ensuring that components, intermediates, drug substance, and drug product are of the quality required for their intended use and that quality systems are maintained. The Associate Director of Quality Assurance will have a strong leadership role within Duke, the Office of Regulatory Affairs and Quality (ORAQ), and with other GMP quality assurance staff, which may include managing GMP QA staff, GMP QC staff, and/or other GMP functions. This position will serve as an expert resource and provide guidance regarding interpretation and applicability of US (and global as appropriate) GMP requirements. The position will work with ORAQ leadership to support the GMP programs at Duke University, including release of products/clinical trial material, assistance with deviation and event management, review of vendor qualifications, and oversight of component control and disposition. The Associate Director of QA will function as central point of contact and serve as a daily liaison for strategic issue resolution and oversight of major cGMP quality systems. This position will consult with manufacturing operations staff, as applicable/requested, to serve as a resource. This position reports to the Director, Quality.
- In conjunction with ORAQ leadership but functioning independently:
- Architect of robust quality management program for various facilities and teams with multiple products and platforms in varying stages of GMP product development. Oversee creation and maintenance of those systems.
- Ensure quality oversight and real-time GMP support are provided to activities being conducted in a manufacturing operation, including quality assurance and quality control testing of products.
- Build and lead strategic initiatives for GMP programs at Duke in diverse developmental areas.
- Synthesize and apply knowledge/input from FDA or external sponsors to other, related products, as applicable.
- Collaborate with GMP facility leadership and staff to manage development, coordination, and implementation of complex projects issues, including but not limited to deviations, product release concerns, and out of specifications.
- The scope of the required knowledge includes an understanding of regulations related to GMP as well as numerous, diverse products, such as drugs (ex. small molecules, antibodies), biologics (ex. vaccines, cellular/tissue based therapy products), medical devices, and/or blood products/HCT/Ps.
- Collaborate with end users about quality related issues and implement actions.
- Liaise between Duke facilities and external entities, including regulatory agencies and external sponsors or vendors.
- Oversee programs that are both internally sponsored and also externally sponsored, where Duke may serve as a Contract Manufacturing Organization (CMO).
- Serve as a quality representative on project teams and assure the progress of projects by providing direction, solutions, and feedback to the teams.
- Facilitate the progress of clinical research/programs in all stages of development by developing and assisting with the implementation of thoughtful and appropriate GMP quality strategies.
- Support both internal and external audits and regulatory inspections with a quality focus or in partnership with subject matter expert (SME).
- Supervise, coordinate and lead the work of GMP Quality Assurance staff, as well as other GMP staff (ex. Quality Control) and provide feedback, as appropriate.
- Guide and lead by setting realistic personal goals for staff and provide regularly scheduled feedback throughout the year.
- Interact with Duke and GMP facility leadership, as well as other offices, on behalf of ORAQ to facilitate projects, address concerns/risks, and/or provide information/metrics, as applicable.
- Provide creative and innovative solutions to GMP issues while being an advocate for compliance.
- Actively participate in and lead the design and implementation of processes.
- Monitor and analyze existing and proposed laws, regulations, guidances, and policy statements to advise GMP manufacturing teams on compliance and risk management for relevant projects.
- Develops and delivers educational seminars to provide direction to Duke investigators, ORAQ, and external entities.
- Represents ORAQ in certain FDA Agency interactions, internal University discussions, and external meetings.
- Represent the QA team at Upper Management meetings.
- The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Required: Bachelor of Science or Bachelor of Arts degree
Preferred: Master's degree or PhD
Minimum 5 years of experience in a GxP regulated environment. Leading projects and teams with measurable deliverable outcomes Experience in representing the QA Department at upper level management meetings and/or outside of the organization. Making QA decisions independently. Experience in representing department in audits and inspections. Managing team related projects. Experience in monitoring the overall effectiveness of the in place quality systems and gap analysis.
OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
- Expert knowledge of GxP
- Must possess strong communicating skills with the ability to communicate effectively up down, and across, at all levels of the organization
- Demonstrates comprehensive decision-making skill by taking independent and timely decisions; communicates, influences and escalates issues, and serves as final authority, as appropriate.
- Strong partnering and negotiating with multiple internal, and frequently also external stakeholders.
- In conjunction with ORAQ leadership, be a leader with a clear understanding of regulatory expectations.
- Ability to hire, develop and retain top talent for the QA team.
- Capability of leading multiple projects within multidisciplinary environments at the same time.
- Team player with sense of urgency to carry out tasks in a timely and accurate manner.
- Possess an acute attention to detail and be exceedingly good at multitasking.
- Ability to interact well with employees at all levels.
- Strong organizational skills.
- Excellent verbal, written, and interpersonal skills.
- Possess good problem-solving skills.
- Adapt to changing priorities effectively.
- Ability to work independently on assignments.
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.