💼 About This Role

You'll lead the Quality Assurance Department for a new Commercial Manufacturing Facility, building and implementing the Commercial QA program. Your work will ensure cGMP and regulatory compliance across all product life cycles.

🎯 What You'll Do

• Lead and mentor QA personnel, including hiring and performance evaluations
• Oversee investigations, CAPAs, change management, and document control
• Support internal audits, client audits, and regulatory inspections
• Manage QA budget and ensure resource allocation

📋 Requirements

• 15+ years of GMP and Quality experience in Pharma/Biotech
• 10+ years in a QA management role
• Expert knowledge of cGMP guidelines for late-phase/commercial programs
• Experience with regulatory inspections by FDA and EU authorities

✨ Nice to Have

• Experience building and developing QA programs
• Advanced degree in a scientific discipline

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Recruiter Phone Screen· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Panel Interview· 90 min