Associate Director, GMP Quality

About the role

The Associate Director, GMP Quality oversees GMP activities related to Olema's products, including small molecule drug substances (APIs) for both clinical and commercial use. Responsibilities include batch disposition/release, technical review, quality oversight, and supporting supplier compliance. The role involves collaborating with various functional teams, preparing submissions, ensuring quality and compliance, and interacting with Qualified Persons (QPs).

Responsibilities

• Perform batch disposition/release for Clinical Trial Materials and Commercial batches
• Conduct technical reviews, quality oversight, and approvals of Master Batch Records and Executed Batch Records
• Review and approve deviations, CAPAs, and change controls, and open internal shadow records when required
• Review and approve Quality Control records such as Certificate of Analysis, Analytical Testing, Method Validation, and Stability reports
• Oversee operational aspects of Olema's Contract Manufacturing Organizations (CMOs) as specified in quality agreements
• Represent Olema as Person in Plant (PIP) during critical processing
• Support Pre-Approval Inspection readiness for NDA/Commercial launch
• Review sections of New Drug Applications for content and accuracy
• Support Supplier audits and manage Supplier compliance
• 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 Standard Operating Procedures (SOPs) as required

Requirements

• A love of challenging, important work
• Bachelor’s degree in relevant field, with advanced degree (MS, PharmD, PhD) preferred
• 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
• Experience with small molecule synthesis and analytical test record review
• Prior experience with NDA/BLA submission and commercial launch for pharmaceutical products
• 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

Pay

The base pay range for this position is expected to be $160,000 - $180,000 annually.