Manager, Shop Floor Quality Assurance, Cell Therapy
Core
Lead a team of 4-8 QA specialists on the shop floor to ensure 24x7 quality oversight, compliance with cGMP, and resolution of manufacturing issues in a Cell Therapy facility.
Role type
Manager, Shop Floor Quality Assurance
Builds
Cell Therapy medicines
Domain
Biopharmaceuticals / Cell Therapy / Manufacturing
Required skills
cGMP compliance, deviation and CAPA management, aseptic/sterile environment operations, batch record review, team leadership, quality risk management, MES/ERP system proficiency
Preferred skills
microbial controls, contamination mitigation strategies, change control management
Technologies
Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP), SAP, TrackWise, Veeva
Responsibilities
Provide leadership for on-the-floor quality oversight and triage of unexpected events; Review and interpret manufacturing batch records and logbooks; Serve as a subject matter expert for quality management system issues; Coach and mentor operators and Field QA specialists; Interview, hire, and develop direct reports; Proactively identify and address quality risks and critical issues.
Seniority
Manager, team lead