💼 About This Role

You'll serve as the QA lead for QC laboratory operations in a regulated cell therapy manufacturing environment. Your role ensures compliance with cGMPs and data integrity principles, maintaining audit readiness. You'll drive quality across analytical and microbiology labs through cross-functional collaboration.

🎯 What You'll Do

• Review and approve laboratory documentation including raw data and test results.
• Support laboratory quality events: deviations, OOS/OOT investigations, CAPAs.
• Review change controls, method validations, equipment qualifications, and SOPs.
• Conduct GxP walkthroughs of QC labs and lead inspection readiness activities.

📋 Requirements

• Bachelor's degree in Life Sciences or related field.
• Minimum 8 years of QA/QC experience in regulated biopharma or cell therapy.
• Experience reviewing cGMP laboratory data.
• Experience supporting laboratory investigations (deviations, OOS, OOT).