CQV Supervisor

Role: CQV Supervisor overseeing commissioning, qualification, and validation activities for a cell therapy manufacturing facility. Responsibilities: lead and manage validation programs for facilities, utilities, equipment, and computerized systems, ensuring compliance with cGMP and regulatory standards (e.g., 21 CFR Parts 11, 210, 211); develop protocols, author validation documents, investigate deviations, and support change controls; serve as SME during audits and inspections; collaborate across Engineering, Quality, Manufacturing, Facilities, and Automation teams to maintain validated, compliant systems; drive continuous improvement and remediation efforts. Requirements: Bachelor's in Engineering, Life Sciences, or related field; 8+ years in CQV, Quality, or Manufacturing within regulated biopharma, with up to 3 years of supervisory experience; deep knowledge of FDA and global GMP regulations, validation lifecycle, and aseptic cell therapy manufacturing; experience supporting regulatory inspections, validation, and lifecycle management of GMP systems. HighValue: cell therapy (CAR-T, biologics), facility validation, regulated manufacturing, cGMP compliance, regulatory audits, lifecycle documentation, cross-functional leadership, risk-based validation. WorkSetup: on-site with potential for cross-team collaboration; travel specifics not detailed.