Associate Director, GMP Quality

About the role

The Associate Director, GMP Quality oversees GMP activities for Olema's products, focusing on the manufacture of small molecule drug substances (Active Pharmaceutical Ingredients). Responsibilities include reviewing Certificate of Analysis, Batch Disposition, Person in Plant oversight, and supporting Supplier compliance. This role collaborates with CMC, Regulatory, and Supply Chain teams to prepare submissions and ensure quality and compliance.

• Batch disposition/release for Clinical Trial Materials and Commercial batches
• Perform technical review, quality oversight, and approvals
• Review and approve CMO deviations, CAPA, and Change Controls
• Operational oversight of Olema's CMOs as specified in quality agreements
• Represent Olema 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
• Support Supplier audits as necessary
• Interact with Qualified Persons (QP) to facilitate the release of Clinical and Commercial product
• Generate metrics for Quality Management Reviews
• Contribute and participate in Annual Product Quality Reviews of commercial products
• Represent GMP Quality during internal and regulatory inspections
• Author Quality department SOPs as required

Requirements

• A love of challenging, important work
• Minimum of 8 years' work experience in an FDA regulated Pharmaceutical GMP / GMP QA role
• Extensive understanding and knowledge of industry standards, concepts, and current cGMP (21 CFR Parts 210 and 211), EudraLex Volume 4, ICH Q7 and other agency standards and guidance
• Prior experience with small molecule synthesis and analytical test record review
• Familiarity with effective Quality Systems and performing robust investigations
• Experience with Health Authority filings and EU QP queries
• Experience managing CMO relationships and supporting CMO inspections
• Experience with Quality Management Systems such as Veeva or TrackWise
• Proven track record of leadership, communication, adaptability, and collaboration
• Clear, concise writing skills and good verbal presentation skills
• Ability to prioritize, work independently, and mindfully engage with others