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DIR, GMP QUALITY
Job Title: DIR, GMP QUALITY
Job Code: 2765
FLSA: E
Job Level: 93
Revised Date: 02/01/2022
Job Family: JF 05
Occupational Summary
Directs, manages, and supervises GMP quality assurance (QA) and quality control (QA) activities within the Duke University School of Medicine (SOM) Office of Regulatory Affairs and Quality (ORAQ) and affiliated GMP manufacturing facilities on campus. ORAQs responsibilities include quality assurance oversight of medical products manufactured on Duke University regulated by the U.S. Food and Drug Administration (FDA). ORAQ oversees the manufacturing and release of unapproved, or investigational, medical products used in research studies as well as licensed products approved by FDA in a marketing application. 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.
The Director is responsible for developing, coordinating and maintaining systems and procedures that support GMP compliance with federal regulations, guidelines, and applicable laws. In conjunction with ORAQs Executive Director, the Director develops and executes GMP QA and QC visions and strategies within the office and across the University as well as oversight of certain GMP quality assurance and quality control activities. As the leader within the ORAQ Quality team, the Director oversees GMP Quality work for Duke and represents the office and GMP quality staff in Agency, University, and external sponsor interactions. The Director provides leadership and direction through managers and senior professional staff within the office.
Work Performed
Directs, manages, and supervises GMP Quality teams and quality systems within supported GMP facilities at Duke University including, but not limited to, release of products/clinical trial material, assistance with deviation and event management, review of corrective and preventive actions, and oversight of component control and disposition. Through the developed GMP quality systems, ensure compliance with federal regulations, guidelines, and applicable laws.
In conjunction with ORAQ leadership, oversees GMP quality management system(s) and standard operation procedure (SOP) requirements for investigational and licensed medical products manufactured on campus, including cases where Duke serves as a contract manufacturing organization (CMO). Provide creative and innovative solutions to GMP issues while being an advocate for compliance.
Interacts effectively, collaboratively, and transparently with other offices at Duke, providing strategic guidance and support for questions or projects. Interfaces with University leadership, research support offices, Good Manufacturing Practice (GMP) facilities, project teams and regulatory agencies to address identified GMP issues.
Serves as a leader within ORAQ and within supported GMP facilities on campus, providing guidance and assistance with the development, coordination, and implementation of multifaceted GMP QA projects, such as GMP facility construction/changes, novel product development and transfer to the GMP setting, as well as complex deviations, events, CAPAs, and changes. 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.
Establishes and maintains effective relationships with applicable regulatory and accreditation agencies, especially the US FDA, as it pertains to supporting facilities manufacturing on campus. Support both internal and external audits and regulatory inspections with a quality focus or in partnership with subject matter experts (SMEs).
Represents ORAQ in internal University discussions and external collaborations, including company and government sponsors. Provides feedback and input on strategic direction of the GMP QA systems within overseen Duke facilities/programs and drives implementation of new initiatives.
Develops and delivers educational seminars on GMP and related topics to ORAQ and supported GMP facilities on campus. Remains current on applicable federal regulations.
Monitors and analyzes existing and proposed laws, regulations, guidances, and policy statements to advise ORAQ staff and supported GMP programs on compliance and risk management for relevant projects. Monitor and oversee metrics and/or KPIs
Oversees systems and workflows, including standard operating procedures (SOPs), necessary to support robust GMP manufacturing within relevant facilities.
Develops GMP quality organizational structures and functions that support Dukes GMP needs as well as supports the specific GMP facilities supported by that Quality team.
Directly supervises ORAQ GMP Quality staff. Develops action plans with direct reports to ensure the continued success of the office and to ensure work is completed effectively, accurately, and on time. Mentors, coaches, and manages direct and indirect reports to foster professional development and retention of talent.
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 Qualifications at this Level
Education/Training
Required: Bachelors degree in a life science field (i.e., biology, chemistry, zoology, etc.) or health related discipline (i.e., nursing, pharmacy, or allied healthcare field) required.
Preferred: Strongly prefer candidates with a Masters degree or other formal post-graduate training in a clinical discipline, quantitative science, or related field (PharmD, PhD, MPH).
Experience
Required: Ten years of experience in an organization involved in the conduct of clinical research such as a pharmaceutical, biotechnology, or medical device company; contract research organization; academic medical center; or regulatory agency. Five years experience and advanced knowledge directly related to regulatory services and/or regulatory compliance.
OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Skills
Required: None Preferred: Regulatory Affairs Certification by the Regulatory Affairs Professionals Society
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
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 University 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.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job 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.
