💼 About This Role

You'll oversee external manufacturing quality for finished goods at a clinical-stage gene therapy company. You'll ensure compliance with late-stage clinical and commercial regulatory requirements. This role offers strategic leadership across internal and cross-functional CMC teams.

🎯 What You'll Do

• Lead cross-functional production teams to meet quality and program milestones.
• Drive preparation and execution of PPQ and comparability campaigns.
• Oversee critical investigations and implement effective CAPAs.
• Represent Quality in internal and external operational forums.

📋 Requirements

• Bachelor's degree in biological sciences or related field.
• 13+ years of progressive pharmaceutical industry experience in Manufacturing, Quality Control, and Quality Assurance.
• Expert knowledge of multi-regional quality system regulations (ICH, US, EU).
• Experience presenting and responding to regulatory agency audits.

✨ Nice to Have

• Experience with cold and ultra-cold chain.
• Ability to develop, coach, and mentor employees.
• Risk management application experience.

🎁 Benefits & Perks

• 🏖️ Remote work flexibility.
• 💼 Contract role with competitive hourly rate.