💼 About This Role

You'll lead the Clinical QA department to ensure compliance with cGMP, FDA, and EU guidelines for pharmaceutical products. You'll drive risk mitigation, harmonize quality processes, and support client interactions, audits, and regulatory inspections. This role offers the chance to shape quality strategy in a biotech environment.

🎯 What You'll Do

• Lead and mentor Clinical QA team members
• Implement and improve quality systems and facility validation
• Serve as QA liaison for client projects
• Oversee documentation including SOPs, protocols, and risk assessments

📋 Requirements

• 10+ years GMP and quality experience in pharma/biotech
• 5+ years in a QA management role
• Bachelor's degree in a scientific discipline
• Experience with FDA and EU regulatory inspections

✨ Nice to Have

• Advanced degree in a scientific field
• Knowledge of aseptic manufacturing processes