💼 About This Role

You'll manage quality systems including deviations, change controls, and batch disposition for cell therapy products at a late-stage biotechnology company. You'll ensure compliance with regulatory standards and support the rapid release of therapies for patients in clinical trials.

🎯 What You'll Do

• Oversee deviations, change controls, CAPAs, and document control
• Evaluate batch records for release decisions
• Maintain document management system compliance
• Provide training on quality systems and processes

📋 Requirements

• Bachelor's degree in scientific discipline
• 3+ years in quality control testing or GMP
• Understanding of FDA regulations and GMP
• Experience in GMP within cell therapy or biopharma

✨ Nice to Have

• Prior internal audit experience
• Document control management experience

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Phone Screen· 30 min
2. 2Technical Interview· 45 min
3. 3Onsite Interview· 2 hours