Associate Director, GMP Quality
$160,000–$180,000 year
On-siteSan Francisco, California, United States
Job Summary
Oversee GMP activities for clinical and commercial small molecule drug substances, including batch disposition/release, technical review of Master and Executed Batch records, and approval of CMO deviations, CAPAs, and change controls. Perform quality oversight by reviewing Certificate of Analysis, analytical testing, method validation, and stability reports while representing Olema as Person in Plant for critical processing. Collaborate with CMC, Regulatory, and Supply Chain teams to prepare submissions, ensure compliance, and support Pre-Approval Inspection readiness for NDA and commercial launch. Generate metrics for Quality Management Reviews, conduct Annual Product Quality Reviews, and author SOPs as required.
Required Qualifications
- Bachelor's degree
- Advanced degree (MS, PharmD, PhD) preferred
- 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 as they relate to GMP Quality Assurance
- Minimum of 8 years' work experience in an FDA regulated Pharmaceutical GMP / GMP QA role
- 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
- Proficient in Word, Excel, PowerPoint, SharePoint
- Demonstrated proven track record of leadership, communication, adaptability, and collaboration
- Communicate decisions and recommendations with clear background and justification
- A strong team player with the ability to focus on project objectives with an emphasis on quality
- Clear, concise writing skills and good verbal presentation skills
- Ability to prioritize, work independently, and mindfully engage with others
- 10-15% travel, some international
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