Associate Director, GMP Quality
Olema Oncology
August 06, 2026
On-site
San Francisco, CA
Operations
Associate Director, GMP Quality (San Francisco or Boston)
Responsibilities (primarily):
- Batch disposition/release for Clinical Trial Materials and Commercial batches
- Technical review, quality oversight, and approvals of Master Batch Records and Executed Batch Records
- Review/approval of CMO Deviations, CAPA, and Change Controls; open internal shadow records when required
- Technical review of Quality Control records (COAs, analytical testing, method validation, stability reports)
- Operational oversight of CMOs per quality agreements (may include periodic CMO visits)
- Serve as Person in Plant (PIP) when critical processing occurs
- Support Pre-Approval Inspection readiness for NDA/commercial launch
- Review NDA sections for content and accuracy
- Review Quality Agreements and support Supplier audits
- Interact with Qualified Persons (QP) to facilitate release of Clinical and Commercial product
- Generate metrics for Quality Management Reviews; participate in Annual Product Quality Reviews
- Represent GMP Quality during internal and regulatory inspections
- Author Quality department SOPs as required
Qualifications:
- Bachelor’s degree required; MS/PharmD/PhD preferred
- 8+ years in FDA-regulated Pharmaceutical GMP/GMP QA
- Extensive knowledge of cGMP (21 CFR Parts 210/211), EudraLex Vol. 4, ICH Q7, and agency GMP guidance
- Experience with small molecule synthesis and analytical record review
- NDA/BLA submission and commercial launch experience
- Quality systems and robust investigations; Health Authority filings and EU QP queries
- CMO relationship management and inspection support
- Familiarity with Veeva or TrackWise
- Proficient in Word, Excel, PowerPoint, SharePoint
Skills/Attributes:
- Leadership, communication, adaptability, collaboration
- Clear, justified decision-making; strong writing and presentation
- Independent prioritization and teamwork
Benefits: Competitive compensation and benefits package; equity and bonus included in total compensation.
Application instructions: Not specified.
Responsibilities (primarily):
- Batch disposition/release for Clinical Trial Materials and Commercial batches
- Technical review, quality oversight, and approvals of Master Batch Records and Executed Batch Records
- Review/approval of CMO Deviations, CAPA, and Change Controls; open internal shadow records when required
- Technical review of Quality Control records (COAs, analytical testing, method validation, stability reports)
- Operational oversight of CMOs per quality agreements (may include periodic CMO visits)
- Serve as Person in Plant (PIP) when critical processing occurs
- Support Pre-Approval Inspection readiness for NDA/commercial launch
- Review NDA sections for content and accuracy
- Review Quality Agreements and support Supplier audits
- Interact with Qualified Persons (QP) to facilitate release of Clinical and Commercial product
- Generate metrics for Quality Management Reviews; participate in Annual Product Quality Reviews
- Represent GMP Quality during internal and regulatory inspections
- Author Quality department SOPs as required
Qualifications:
- Bachelor’s degree required; MS/PharmD/PhD preferred
- 8+ years in FDA-regulated Pharmaceutical GMP/GMP QA
- Extensive knowledge of cGMP (21 CFR Parts 210/211), EudraLex Vol. 4, ICH Q7, and agency GMP guidance
- Experience with small molecule synthesis and analytical record review
- NDA/BLA submission and commercial launch experience
- Quality systems and robust investigations; Health Authority filings and EU QP queries
- CMO relationship management and inspection support
- Familiarity with Veeva or TrackWise
- Proficient in Word, Excel, PowerPoint, SharePoint
Skills/Attributes:
- Leadership, communication, adaptability, collaboration
- Clear, justified decision-making; strong writing and presentation
- Independent prioritization and teamwork
Benefits: Competitive compensation and benefits package; equity and bonus included in total compensation.
Application instructions: Not specified.