Director GMP QA
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The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.
This role will oversee quality operations, vendor compliance, regulatory readiness, and support for clinical development and manufacturing activities, ensuring alignment with global health authority requirements.
Key Responsibilities:
Lead QA team and quality systems for GMP/GLP compliance
Manage audits, regulatory inspections, and CAPA processes
Oversee vendor and contract partner quality performance
Contribute to regulatory submissions and inspection preparedness
Advise leadership on quality strategy and risk management
Qualifications:
10+ years in QA leadership within biopharma, ideally with small molecule experience
Strong knowledge of global GMP/GLP regulations (FDA, EMA, ICH, etc.)
Experience with CDMOs, regulatory submissions, and quality systems
Strong leadership, communication, and problem-solving skills
Details:
Candidates must be local. Hybrid on-site work model with limited travel.
Seniority level Seniority levelDirector
Employment type Employment typeFull-time
Job function Job functionQuality Assurance
IndustriesBiotechnology Research and Pharmaceutical Manufacturing
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- Location:
- San Francisco, CA
- Salary:
- $250
- Category:
- Management And Consultancy