Senior Manager, Quality Assurance Shop Floor
Core
Senior leader ensuring highest quality standards in cGMP Cell Therapy processes, overseeing shop-floor activities including manufacturing, release testing, and packaging of autologous drug product.
Role type
Senior Manager, Quality Assurance Shop Floor
Builds
Autologous cell therapy drug products
Domain
Biopharmaceuticals / Cell Therapy / cGMP Manufacturing
Required skills
cGMP compliance, quality management systems, aseptic/sterile environment operations, deviation and CAPA management, batch record management, cross-functional collaboration, team leadership, strategic planning, problem-solving, stakeholder negotiation, technical writing
Preferred skills
microbial controls, contamination mitigation strategies, GxP electronic systems (MES, ERP, LIMS, QMS)
Technologies
SAP, TrackWise, Veeva, Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS), Quality Management Systems (QMS)
Responsibilities
Lead and mentor day-shift managers and teams; uphold and improve quality standards through cross-functional collaboration; develop and implement training programs; solve complex quality issues and drive continuous improvement; provide leadership for routine on-the-floor quality oversight; act as subject matter expert for audits and inspections; approve deviation records; coach and develop staff.
Seniority
Senior Manager, hands-on leadership