Manager Quality Assurance Operations
Core
Provide on-the-floor Quality Assurance (QA) oversight for GMP cell therapy manufacturing operations, ensuring compliant execution, review, and disposition of manufacturing activities, materials, and documentation.
Role type
Manager, Quality Assurance Operations (Cell Therapy)
Builds
Clinical and commercial cell therapy products
Domain
Biopharmaceuticals / Cell Therapy / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, batch record review, lot disposition, deviation management, CAPA, change control, supplier qualification, aseptic processing knowledge, leadership, cross-functional collaboration
Preferred skills
Cell therapy/ATMP experience, advanced degree, prior leadership at Catalent, raw material release experience
Technologies
GMP regulations (21 CFR Parts 210/211, 600-series, EU GMP, ICH), QMS, SOPs
Responsibilities
Provide real-time QA on-the-floor support for aseptic processing and cell handling; Perform GMP walkthroughs and observe critical manufacturing steps; Review executed batch production records and logbooks for accuracy and compliance; Support timely batch record review and participate in lot disposition and release decisions; Perform QA review, approval, and release of raw materials and critical reagents; Review, assess, and approve deviations, nonconformances, investigations, CAPAs, and change controls; Support inspection readiness activities and participate in regulatory inspections and client audits; Provide day-to-day leadership and QA guidance while collaborating cross-functionally with Manufacturing, Supply Chain, MS&T, Validation, and Regulatory Affairs.
Seniority
Manager, hands-on leadership with direct reports