Director, Quality Assurance (GMP)
$198,000–$235,500 year
Hybrid · Pasadena, California, United States or San Diego, California, United States
Job Summary
Director of Quality Assurance (GMP) leads QA oversight for GMP manufacturing and testing activities at external vendors, ensuring compliant product release, effective vendor management, and alignment with global GxP standards. Oversees and performs QA product release activities, reviews GMP vendor documentation, and represents QA in vendor/product team meetings. Responsible for root cause investigations, corrective actions, change controls, deviations, and CAPA, while driving continuous improvement and governance with cross-functional stakeholders. Manages and develops QA staff, maintains knowledge of regulatory expectations for pharmaceutical development and commercialization, and supports vendor performance reviews. This role requires occasional travel between the Pasadena and San Diego offices in a hybrid work model and is a full-time leadership position.
Required Qualifications
- Bachelor’s degree in a scientific discipline
- minimum 12 years of directly related Quality Assurance experience
- Quality Assurance experience in CMC manufacturing and project management
- strong communication and cross-functional collaboration skills
- ability to travel occasionally between Pasadena and San Diego offices
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