Associate Director, GMP Quality
Olema Oncology
August 06, 2026
On-site
Cambridge, MA
Operations
Associate Director, GMP Quality
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/approve CMO deviations, CAPA, and Change Controls; open internal shadow records when required
- Technical review of Quality Control records (e.g., Certificate of Analysis, 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 sections of New Drug Applications 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; contribute to Annual Product Quality Reviews
- Represent GMP Quality during internal and regulatory inspections
- Author Quality department SOPs as required
Qualifications / Key requirements:
- Bachelor’s degree required; MS/PharmD/PhD preferred
- Extensive understanding of industry standards and current cGMP (21 CFR Parts 210/211), EudraLex Vol. 4, ICH Q7 and related GMP Quality Assurance guidance
- Minimum 8 years in an FDA-regulated Pharmaceutical GMP/GMP QA role
- Experience with small molecule synthesis and analytical test record review
- Prior NDA/BLA submission and commercial launch experience
- Familiarity with Quality Systems and robust investigations; Health Authority filings and EU QP queries
- Experience managing CMO relationships and supporting CMO inspections
- Experience with Quality Management Systems (e.g., Veeva or TrackWise)
- Proficient in Word, Excel, PowerPoint, SharePoint
Skills/attributes:
- Leadership, communication, adaptability, collaboration
- Clear writing and verbal presentation; ability to prioritize and work independently
Travel: 10–15% (some international)
Compensation/benefits:
- Base pay range: $160,000–$180,000 annually; total compensation includes equity, bonus, and benefits. A Summary of Benefits is available for applicants.
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/approve CMO deviations, CAPA, and Change Controls; open internal shadow records when required
- Technical review of Quality Control records (e.g., Certificate of Analysis, 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 sections of New Drug Applications 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; contribute to Annual Product Quality Reviews
- Represent GMP Quality during internal and regulatory inspections
- Author Quality department SOPs as required
Qualifications / Key requirements:
- Bachelor’s degree required; MS/PharmD/PhD preferred
- Extensive understanding of industry standards and current cGMP (21 CFR Parts 210/211), EudraLex Vol. 4, ICH Q7 and related GMP Quality Assurance guidance
- Minimum 8 years in an FDA-regulated Pharmaceutical GMP/GMP QA role
- Experience with small molecule synthesis and analytical test record review
- Prior NDA/BLA submission and commercial launch experience
- Familiarity with Quality Systems and robust investigations; Health Authority filings and EU QP queries
- Experience managing CMO relationships and supporting CMO inspections
- Experience with Quality Management Systems (e.g., Veeva or TrackWise)
- Proficient in Word, Excel, PowerPoint, SharePoint
Skills/attributes:
- Leadership, communication, adaptability, collaboration
- Clear writing and verbal presentation; ability to prioritize and work independently
Travel: 10–15% (some international)
Compensation/benefits:
- Base pay range: $160,000–$180,000 annually; total compensation includes equity, bonus, and benefits. A Summary of Benefits is available for applicants.