Associate Director, GMP Quality

Associate Director, GMP Quality

• 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/approve CMO deviations, CAPA, and Change Controls; open internal shadow records when required
• Technical review of Quality Control records (e.g., 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) when critical processing occurs
• Support Pre-Approval Inspection readiness for NDA/commercial launch
• Review sections of New Drug Applications for content and accuracy
• Review Quality Agreements and support supplier audits
• Interact with Qualified Persons (QP) to facilitate release of Clinical and Commercial product
• 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 / Key requirements:

• Bachelor's degree required; MS/PharmD/PhD preferred
• Extensive understanding of industry standards and current cGMP (21 CFR Parts 210/211), EudraLex Vol. 4, ICH Q7 and related GMP Quality Assurance guidance
• Minimum 8 years in an FDA-regulated Pharmaceutical GMP/GMP QA role
• 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; Health Authority filings and EU QP queries
• Experience managing CMO relationships and supporting CMO inspections
• Experience with Quality Management Systems (e.g., Veeva or TrackWise)
• Proficient in Word, Excel, PowerPoint, SharePoint

Skills/attributes:

• Leadership, communication, adaptability, collaboration
• Clear writing and verbal presentation; ability to prioritize and work independently

Travel: 10-15% (some international)

Compensation/benefits:

• Base pay range: $160,000-$180,000 annually; total compensation includes equity, bonus, and benefits. A Summary of Benefits is available for applicants.