GMP Quality Associate Director — Lead Clinical Batches

Olema Oncology; San Francisco (CA); On-site; USD 160,000 - 180,000; Full time

Job summary

Olema Oncology is seeking an Associate Director, GMP Quality to oversee GMP activities for clinical and commercial products, including review of batch records and supplier compliance. The role requires collaboration with CMC, Regulatory, and Supply Chain functions and may involve visits to CMOs.

Based in San Francisco or Boston with 10–15% travel. The ideal candidate has a strong background in FDA-regulated GMP QA, NDA/BLA submissions, and quality systems experience, with leadership and

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 8+ years in an FDA regulated GMP/GQA role in pharma.
• Experience with NDA/BLA submissions and commercial launch.
• Familiarity with Quality Management Systems (Veeva or TrackWise).
• Experience managing CMO relationships and inspections.
• Proficient in Microsoft Office (Word/Excel/PowerPoint) and SharePoint.

Responsibilities

• Batch disposition/release for Clinical Trial Materials and Commercial batches.
• Technical review/oversight and approvals of Master/Executed Batch records.
• Review/approval of CMO deviations, CAPA, and Change Controls.
• Review Quality Control records including CoA, testing, method validation, stability.
• Oversee CMOs per quality agreements; occasional visits to CMOs.
• Represent GMP Quality during inspections and prepare NDA/commercial submissions.
• Draft and maintain Quality department SOPs and support supplier audits.

Job description

Olema Oncology is seeking an Associate Director, GMP Quality to oversee GMP activities for clinical and commercial products, including review of batch records and supplier compliance. The role requires collaboration with CMC, Regulatory, and Supply Chain functions and may involve visits to CMOs.

Based in San Francisco or Boston with 10–15% travel. The ideal candidate has a strong background in FDA-regulated GMP QA, NDA/BLA submissions, and quality systems experience, with leadership and