Scientist, QC Compliance, Cell Therapy

Role: Lead QC compliance for cell therapy manufacturing, specializing in deviations, investigations, CAPAs, change controls, and process improvements. Responsibilities: author and oversee QC deviation reports, conduct root cause analysis, ensure timely closure of investigations, generate KPIs, report escalation risks, and support document revisions; mentor colleagues and represent department during inspections. Requirements: Bachelor’s in science/engineering, 6+ years in biopharma QC labs, with at least 2 years in investigation; strong knowledge of cGMP, quality systems, and technical writing. Preferred: experience with cell therapy analytical/microbiological testing, investigations, and root cause analysis techniques. High-Value: focus on cell therapy modalities, investigations in GMP manufacturing, cross-functional collaboration, compliance with global regulatory standards, and representing QC in inspections. WorkSetup: not specified, but role involves laboratory and compliance activities.