Senior GMP Quality Director Small Molecules (Clinical/Commercial)

Olema Oncology; Boston (MA); On-site; USD 160,000 - 180,000; Full time

Job summary

Olema Oncology seeks an Associate Director GMP Quality to oversee GMP activities for clinical and commercial products, focusing on small molecule drug substances. You will review analytical development and QC results, COAs, batch disposition, and support supplier compliance.

Based in San Francisco or Boston with 10–15% travel, the role partners with CMC, Regulatory, and Supply Chain teams to prepare submissions, ensure quality, and represent GMP Quality during inspections.

Qualifications

• 8+ years in FDA-regulated pharmaceutical GMP QA roles.
• Experience with NDA/BLA submissions and commercial launches.
• Experience with CMO management and inspections.
• Familiarity with quality systems and robust investigations.
• Experience with health authority filings and EU QP queries.
• Proficiency in MS Office Suite.

Responsibilities

• Batch disposition and release for clinical and commercial batches.
• Technical review of master and executed batch records for quality and compliance.
• Oversee CMO deviations, CAPA, and change controls; open shadow records when required.
• Technical review of COA, testing, method validation, and stability reports.
• Oversee CMOs operations and periodic visits; act as PIP when needed.
• Support NDA/pre-approval inspection readiness and document readiness.

Skills

Leadership

Communication

Collaboration

Quality assurance

GMP knowledge

Regulatory awareness

Education

Bachelor’s degree; advanced degree preferred

Tools

Veeva

TrackWise

Word

Excel

PowerPoint

SharePoint

Job description

Olema Oncology seeks an Associate Director GMP Quality to oversee GMP activities for clinical and commercial products, focusing on small molecule drug substances. You will review analytical development and QC results, COAs, batch disposition, and support supplier compliance.

Based in San Francisco or Boston with 10–15% travel, the role partners with CMC, Regulatory, and Supply Chain teams to prepare submissions, ensure quality, and represent GMP Quality during inspections.