Associate Director, GMP Quality

Associate Director GMP Quality (San Francisco or Boston; 10–15% travel, some international)

Responsibilities (primarily):
- Batch disposition/release for Clinical Trial Materials and Commercial batches
- Technical review, quality oversight, and approvals of Master Batch records and Executed Batch records
- Review/approval of CMO Deviations, CAPA, and Change Controls; open internal shadow records as required
- Technical review of Quality Control records (Certificate of Analysis, Analytical Testing, Method Validation, Stability reports)
- Operational oversight of CMOs per quality agreements; may include periodic CMO visits
- Serve as Person in Plant (PIP) during critical processing as necessary
- Support Pre-Approval Inspection readiness for NDA/commercial launch
- Review NDA sections for content and accuracy
- Review Quality Agreements; support Supplier audits as necessary
- Interact with Qualified Persons (QP) to facilitate Clinical and Commercial product release
- Generate metrics for Quality Management Reviews; contribute to Annual Product Quality Reviews
- Represent GMP Quality during internal and regulatory inspections
- Author Quality department SOPs as required

Qualifications/Requirements:
- Bachelor’s degree required; MS/PharmD/PhD preferred
- Minimum 8 years in FDA-regulated Pharmaceutical GMP / GMP QA role
- Extensive knowledge of cGMP (21 CFR Parts 210/211), EudraLex Vol. 4, ICH Q7 and agency guidance
- Experience with small molecule synthesis and analytical test record review
- Prior NDA/BLA submission and commercial launch experience
- Familiarity with Quality Systems and robust investigations
- Experience with Health Authority filings and EU QP queries
- Experience managing CMO relationships and supporting CMO inspections
- Experience with Veeva or TrackWise; proficient in Word, Excel, PowerPoint, SharePoint
- Leadership, communication, adaptability, collaboration; clear writing/presentation

Benefits:
- Competitive compensation and benefits package; equity and bonus included in total compensation.

Application instructions:
- None provided.