🛠 Tech Stack

💼 About This Role

You'll lead validation and computer system assurance programs for GMP manufacturing and laboratory systems. Your work will ensure regulatory compliance with FDA and EU standards across clinical and commercial operations. This role drives continuous improvement in data integrity and risk-based validation.

🎯 What You'll Do

• Develop and implement Quality Engineering and CSA strategy
• Oversee validation lifecycle documentation and approvals
• Ensure data integrity compliance across computerized systems
• Lead regulatory inspection readiness and client audits

📋 Requirements

• 10+ years GMP and quality experience in pharmaceutical or biotech
• 5+ years experience in qualification/validation/CSA in QA or technical role
• Bachelor's degree in a scientific discipline
• Experience with FDA and EU regulatory inspections

✨ Nice to Have

• Advanced degree preferred
• Knowledge of GAMP 5 and CSA methodologies

🎁 Benefits & Perks

• 🏖️ PTO
• 💰 Competitive salary
• 🏥 Health insurance
• 📈 401(k) matching

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter screen· 30 min
2. 2Hiring manager interview· 1 hour
3. 3Panel interview· 2 hours