💼 About This Role

You'll lead GMP quality assurance for a clinical-stage biotechnology company advancing novel biologics. You'll partner with Technical Operations to oversee CDMOs and ensure compliance with FDA, EMA, and ICH standards. This role offers the chance to drive quality systems and inspection readiness for pivotal programs.

🎯 What You'll Do

• Assist with GMP audit schedules and execute audits
• Partner with Technical Operations on CDMO oversight
• Oversee batch record review and release for clinical trials
• Maintain GMP quality systems including change control and CAPA

📋 Requirements

• 10+ years of GMP QA experience in biotech/pharma
• Experience auditing and manufacturing monoclonal antibodies or biologics
• In-depth knowledge of FDA, EMA, and ICH GMP regulations
• Experience with CDMO oversight and quality issue resolution

✨ Nice to Have

• Advanced degree in a scientific discipline
• Experience with Quality Management System Regulations
• Experience with analytical instrumentation and validation

🎁 Benefits & Perks

• 📈 Great culture grounded in C.O.R.E. values
• 🏢 Fast-paced dynamic environment
• 💰 Competitive salary and equity
• 🧳 Remote work with travel up to 20%