Cell & Gene Therapy Quality Lead

Job Summary

A company is looking for a Cell & Gene Therapy Quality Lead / Sr. Quality Lead.

Key Responsibilities

• Provide end-to-end quality systems oversight for Cell & Gene Therapy platforms, ensuring compliance with global GMP and ATMP regulatory requirements
• Lead comprehensive review and disposition of deviations impacting Cell & Gene programs, ensuring timely resolution and appropriate risk evaluations
• Serve as Quality SME during audits and regulatory inspections, coordinating documentation and inspection readiness efforts specific to advanced therapy programs

Required Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field
• 7+ years of experience in GMP-regulated pharmaceutical or biotechnology environments, specifically in Cell & Gene Therapy
• Strong expertise in deviation management, CAPA, change control, and quality risk management
• Experience supporting regulatory inspections (FDA, EMA, or other global agencies)
• In-depth understanding of regulatory expectations for advanced therapy quality systems