ASSOCIATE DIRECTOR, QUALITY ASSURANCE

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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System comprise Duke Health, a world-class academic medical center.

About the role

The Office of Regulatory Affairs and Quality (ORAQ) at Duke University is seeking an Associate Director, Quality Assurance to provide strategic leadership for GMP quality programs supporting the development and manufacture of innovative therapies, biologics, vaccines, medical devices, and other regulated products. In this highly visible role, you will serve as a key quality leader, partnering with Duke investigators, GMP facility leadership, regulatory stakeholders, and external sponsors to ensure quality systems effectively support clinical and manufacturing programs. You will help shape and oversee quality management systems across multiple GMP facilities and product platforms, provide expert guidance on regulatory requirements, support inspections and audits, and lead initiatives that advance Duke's mission of translating scientific discoveries into therapies that improve human health. This position reports to the Director, Quality and plays a critical role in supporting compliance, operational excellence, and continuous improvement across Duke's GMP programs.

Responsibilities

• Lead and oversee GMP quality management systems across multiple facilities, product platforms, and development programs to ensure compliance and operational effectiveness.
• Provide strategic quality leadership for GMP initiatives, partnering with ORAQ leadership, investigators, manufacturing teams, and external sponsors to address quality, compliance, and risk management considerations.
• Guide complex quality activities including deviations, investigations, out-of-specification results, product release decisions, CAPAs, and continuous improvement efforts.
• Represent Quality Assurance during audits, regulatory inspections, sponsor interactions, and cross-functional project teams while serving as a trusted subject matter expert.
• Develop and mentor staff by leading quality professionals, fostering professional growth, and supporting a culture of quality throughout Duke's GMP operations.

Requirements

• Bachelor's degree in a scientific discipline (Bachelor of Science or Bachelor of Arts).
• Minimum of five years of experience in a GxP-regulated environment.
• Experience leading complex projects and multidisciplinary teams with measurable outcomes.
• Experience making independent Quality Assurance decisions and providing strategic quality guidance.
• Experience representing Quality Assurance during audits, inspections, and senior leadership meetings.
• Experience evaluating and improving quality systems, including conducting gap assessments and monitoring effectiveness.
• Expert knowledge of GxP regulations and quality systems.
• Demonstrated ability to communicate effectively and influence stakeholders at all organizational levels.
• Proven ability to manage multiple priorities and lead cross-functional initiatives.
• Ability to interpret and apply U.S. and global GMP regulations and regulatory guidance.
• Ability to effectively represent Duke with regulatory agencies, external sponsors, vendors, and other stakeholders.
• Participation in internal and external audits, inspections, and regulatory interactions as needed.
• This position is onsite.

Preferred Qualifications

• Master's degree or PhD in a related scientific field.
• Experience supporting diverse product development programs, including drugs, biologics, cellular therapies, vaccines, medical devices, blood products, and HCT/Ps.
• Experience developing and delivering regulatory or quality training programs.
• Strong organizational, problem-solving, and relationship-management skills.
• Ability to build, mentor, and retain high-performing teams.
• Excellent verbal, written, and interpersonal communication skills.

Benefits

Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more.

Pay

Duke University provides an annual base salary range for this position as USD $109,856.00 to USD $191,062.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.