Executive Director, GMP Quality Assurance
$270,000–$290,000 year
On-siteSan Diego, California, United States
Job Summary
Lead GMP Quality Assurance operations, including document control, training, and material release. Manage compliance activities such as deviations, CAPA, change control, and complaint handling while overseeing batch disposition for clinical materials. Chair quality governance meetings to drive risk-based decision-making and ensure ongoing adherence to FDA, EMA, and global health authority requirements. Serve as the primary lead for health authority inspections and prepare the company for Biologics License Application submissions. Build and lead the GMP QA team, establishing policies, procedures, and quality metrics. Report performance trends and inspection readiness status to executive leadership.
Required Qualifications
- 15+ years of progressive GMP quality assurance experience in biologics, cell therapy, or pharmaceutical manufacturing, including 8+ years in a senior quality leadership role
- Bachelor's degree in life sciences, chemistry, engineering, or a related field
- Deep working knowledge of GMP regulations (21 CFR Parts 210/211, ICH Q7/Q9/Q10)
- Direct, hands-on experience hosting FDA and other health authority inspections
- Primary role in successful BLA and PLI
- Proven track record building and leading GMP QA operations teams and quality systems within a growing biotech or biopharmaceutical company
- Strong knowledge of batch disposition, deviation/CAPA management, change control, and annual product review processes
- Excellent leadership, communication, and cross-functional collaboration skills, with the ability to influence at all levels of the organization
- Demonstrated ability to work independently, exercise sound judgment on complex compliance matters, and make risk-based decisions with minimal oversight
- Ability to travel occasionally as needed
- Ability and willingness to work on-site in San Diego, CA
Desired Qualifications
- Advanced degree or relevant certification (e.g., ASQ CQA, RAC)
- Experience with cell therapy, biologics, or other advanced therapy medicinal products (ATMPs)
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