Associate Director, GMP Quality & Compliance

Duke University; Durham (NC); On-site; USD 110,000 - 191,000; Full time

Job summary

Duke University seeks an Associate Director, Quality Assurance to lead GMP quality programs across multiple facilities and product platforms, partnering with investigators, facility leadership, regulatory stakeholders, and sponsors to ensure quality systems support clinical and manufacturing programs.

You will guide complex QA activities, support inspections, drive continuous improvement, and mentor staff, shaping a culture of quality throughout Duke's GMP operations.

Qualifications

• Bachelor's degree in a scientific discipline (BS/BA).
• Minimum of five years of experience in a GxP-regulated environment.
• Experience leading complex projects 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.

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 experience

Audit leadership

Quality guidance

Stakeholder management

Regulatory knowledge

Education

Bachelor's degree in a scientific discipline

Master's degree or PhD in a related field

Job description

Duke University seeks an Associate Director, Quality Assurance to lead GMP quality programs across multiple facilities and product platforms, partnering with investigators, facility leadership, regulatory stakeholders, and sponsors to ensure quality systems support clinical and manufacturing programs.

You will guide complex QA activities, support inspections, drive continuous improvement, and mentor staff, shaping a culture of quality throughout Duke's GMP operations.