Associate Director, GMP Quality

Olema Oncology · Cambridge, MA · 2 days ago

Science$160k–$180k/yrFull-time

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, quality oversight, review of deviations and CAPAs, and interacting with CMOs and suppliers.

Responsibilities

Perform technical reviews, quality oversight, and approvals for Certificate of Analysis, Batch Disposition, and Master Batch Records
Support Supplier compliance and review deviations, CAPAs, and Change Controls
Operational oversight of CMOs as per quality agreements, including visits and shadow records
Represent Olema as Person in Plant (PIP) during critical processing
Prepare and review sections of New Drug Applications (NDAs) and support Supplier audits
Contribute to Annual Product Quality Reviews and represent GMP Quality during inspections
Generate metrics for Quality Management Reviews and author SOPs as needed

Requirements

Bachelor’s degree in relevant field, with MS/PharmD/PhD preferred
Minimum 8 years’ experience in FDA-regulated pharmaceutical GMP/QA roles
Extensive understanding of industry standards, cGMP, EudraLex, ICH Q7, and other relevant guidelines
Experience with small molecule synthesis and analytical testing
Prior experience with NDA/BLA submissions and commercial launches
Familiarity with Quality Systems and effective investigation techniques
Experience with Health Authority filings and EU QP queries
Proven track record in managing CMO relationships and supporting inspections
Proficiency in Microsoft Office Suite

Qualifications

Demonstrated leadership, communication, adaptability, and collaboration skills
Clear, concise writing and presentation abilities
Ability to prioritize tasks and work independently

Benefits