💼 About This Role

You'll lead all Quality functions across Europe, ensuring compliance with EU GMP/GDP/GCP regulations. You'll drive a proactive quality culture for a late-stage oncology company transitioning from clinical to commercial operations. Your role is critical to supporting regulatory inspections and product launches. Lead the European Quality organization and serve as the key Quality representative for regulatory interactions.

🎯 What You'll Do

• Lead and develop the European Quality organization.
• Act as primary Quality representative to European regulatory authorities.
• Establish and maintain an effective EU Quality Management System.
• Oversee QS processes: deviations, CAPAs, change control, risk management.

📋 Requirements

• Degree in Life Sciences, Pharmacy, or Chemistry.
• 20+ years of GxP Quality experience in pharmaceuticals.
• Deep knowledge of EU regulatory requirements (EMA, EU GMP/GDP).
• Track record of building Quality organizations.

✨ Nice to Have

• Biotech experience.
• Significant leadership with regional/global teams.

🎁 Benefits & Perks

• 🏖️ Flexible remote work.
• 📈 Career growth in a late-stage biotech.
• 🧑‍🤝‍🧑 Collaborative culture.
• 💉 Comprehensive health coverage.
• 💰 Competitive compensation (estimated).

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

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