Quality Assurance Project Manager
Core
Lead and manage Quality Assurance projects for onboarding, technology transfer, and implementation of Cell Therapy and Biologics clients in a GMP manufacturing environment.
Role type
Senior IC Quality Assurance Project Manager
Builds
Quality assurance projects for Cell Therapy and Biologics clients
Domain
Biotechnology / Pharmaceuticals / Cell Therapy / GMP Manufacturing
Required skills
Project management, cGMP regulations, quality systems, client relationship management, cross-functional coordination, risk management, quality agreements, deviation management, investigations, CAPAs, change controls, batch record review
Preferred skills
Cell & Gene Therapy experience, Biologics/CDMO environment experience, TrackWise, SAP, LIMS, PMP certification
Technologies
TrackWise, SAP, LIMS
Responsibilities
Lead QA projects for client onboarding and technology transfer; Manage project lifecycle from initiation to closeout; Develop project scopes, timelines, and governance structures; Serve as primary client-facing quality representative; Coordinate cross-functional teams (QA, QC, Manufacturing, Validation, Supply Chain); Lead project status meetings and communicate progress; Identify risks and develop mitigation plans; Manage Quality Agreements with clients; Support quality systems activities (deviations, investigations, CAPAs, change controls); Generate and maintain project documentation; Drive continuous improvement initiatives
Seniority
Senior, hands-on IC