ASSOCIATE DIRECTOR, QUALITY ASSURANCE

Duke Careers; Durham (NC); On-site; USD 109,856 - 191,062; Full time

Job summary

Duke University’s Office of Regulatory Affairs and Quality is seeking an Associate Director of Quality Assurance to provide strategic leadership for GMP programs spanning development and manufacturing of therapies.

In this highly visible role, you will partner with Duke investigators, GMP facility leadership, regulatory stakeholders, and external sponsors to ensure quality systems effectively support clinical and manufacturing programs.

Qualifications

• 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.
• Demonstrated ability to communicate effectively and influence stakeholders at all organizational levels.
• Proven ability to manage multiple priorities and lead cross-functional initiatives.
• Master's degree or PhD in a related scientific field is preferred.
• Experience supporting diverse product development programs, including drugs, biologics, cellular therapies, vaccines, medical devices, blood products, and HCT/Ps.

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.

Skills

GxP regulations

Quality assurance leadership

Audits & inspections

Regulatory guidance

Cross-functional leadership

Stakeholder communication

Education

Bachelor's degree in science

Master's degree or PhD in related field

Job description

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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 2,600 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. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Be You.

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.

Minimum 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.

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.

Other Requirements:

• 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.

Be Bold.

As the Associate Director, Quality Assurance, you will:

• 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.

Choose Duke.

Duke University is a world-renowned academic and research institution committed to advancing scientific discovery and improving human health. ORAQ supports innovative clinical and manufacturing programs that bring cutting-edge therapies from concept to patient impact while maintaining the highest standards of quality and regulatory compliance.

As part of our team, you will collaborate with leading researchers, clinicians, regulatory professionals, and manufacturing experts while helping shape quality systems that support groundbreaking therapies and research initiatives. This is an opportunity to make a meaningful impact on programs that advance science and improve lives.

Anticipated Pay Range: 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.

Your total compensation goes beyond the dollars on your paycheck. 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 at: https://hr.duke.edu/benefits/

Equal Opportunity Employer: Duke is an 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 (including pregnancy and pregnancy- related conditions), sexual orientation, or military 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 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 reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: [e-mail]; phone: [phone]).

Nearest Major Market: Durham

Nearest Secondary Market: Raleigh

Read more about Duke’s commitment to affirmative action and nondiscrimination at hr.duke.edu/eeo.