💼 About This Role

You'll lead internal and external GMP/GxP audits and manage Quality Agreements for a growing pharmaceutical portfolio. Your work ensures regulatory compliance and continuous improvement of the Quality Management System across clinical and commercial operations.

🎯 What You'll Do

• Plan and conduct internal and external GMP/GxP compliance audits
• Prepare, review, and track audit reports and observations to closure
• Develop, negotiate, and maintain quality agreements with CSPs
• Maintain and improve the internal audit program and SOPs

📋 Requirements

• Bachelor's degree in Life Sciences or related field
• 6 years of progressive QA experience including 3 years in GMP QA
• In-depth knowledge of FDA, EU, and ICH GMP regulations
• Proven experience conducting internal and supplier audits

✨ Nice to Have

• ASQ or ECA academy certification
• European Lead Auditor experience

🎁 Benefits & Perks

• 🏖️ Competitive base, bonus, and equity
• 🏥 Medical, dental, and vision insurance
• 💰 401(k) plan with fully vested match
• 📈 Employee Stock Purchase Plan
• 🧳 Employer-paid life and disability insurance

📨 Hiring Process

Estimated timeline: 3-4 weeks · AI estimate

1. 1Recruiter screen· 30 min
2. 2Hiring manager interview· 60 min
3. 3Panel interview· 90 min