Associate Director, API Quality Assurance (GMP)

📋 Description

• Lead GMP API QA strategy across external manufacturing partners.
• Oversee API and intermediate manufacturing for global GMP and ICH Q7.
• Establish standards for API batch documentation review and traceability.
• Drive deviation investigations, root causes, CAPAs, and effectiveness checks.
• Oversee change control for API processes, specs, analytical methods, and partner changes.
• Manage quality agreements, KPIs, scorecards, and governance with external partners.

🎯 Requirements

• Bachelor’s or Master’s in Chemistry, Chemical Engineering, Pharmacy, or related field.
• 10–12 years GMP pharma/biotech experience focused on API quality.
• Proven API batch disposition, deviation, CAPA, and change control experience.
• Strong knowledge of ICH Q7, ICH Q8–Q11, FDA/EMA regulatory expectations.
• Experience managing external API manufacturers and regulatory inspections.
• Familiarity with Veeva Vault Quality or similar eQMS.

🎁 Benefits

• Competitive annual salary range of $169,000 - $198,000.
• Equity opportunities allowing employees to share in organizational success.
• Performance-based compensation opportunities.
• Comprehensive medical, dental, vision, and life/disability insurance.
• Flexible paid time off programs.
• 401(k) retirement plan options with employer matching.