Executive Director, GMP Quality Assurance

📋 Description

• Head of GMP QA and member of the QA Leadership Team
• Build, lead, and scale a high performing GMP QA team
• Develop and execute the GMP QA strategy aligning with clinical-to-commercial needs
• Establish a GMP QA vision enabling inspection readiness and scalable operations
• Oversee GMP QA systems: deviations, investigations, CAPAs, change control, complaints, and disposition
• Ensure compliance with global GMP regulations and standards and readiness for audits

🎯 Requirements

• 15+ years of GMP QA experience across pharma/biotech/medical devices with global regs
• Proven track record leading GMP QA through clinical-to-commercial transition and launch readiness
• Experience building and scaling GMP Quality Systems; Veeva Quality Suite governance
• Extensive experience managing external manufacturers/testing partners; regulatory inspections
• Strong leadership including coaching and developing senior professionals
• Ability to articulate GMP QA vision aligned with company strategy and adapt leadership style

🎁 Benefits

• Great culture built on CORE values
• Fast-paced environment with growth opportunities
• Competitive compensation and benefits package
• Generous PTO, two company-wide shutdowns annually, and paid sick leave
• Professional development support and resources
• All-team in-person meetings to collaborate