Manager, Shop Floor Quality Assurance, Cell Therapy
Core
Lead a team of 4-8 QA specialists to provide 24x7 on-the-floor quality oversight, ensure compliance with cGMP, and resolve manufacturing issues in a Cell Therapy facility.
Role type
Senior IC Quality Assurance Manager (Cell Therapy)
Builds
High-quality cell therapy products for patients with serious diseases
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Required skills
cGMP compliance, deviation and CAPA management, aseptic/sterile environment operations, batch record review, team leadership, regulatory knowledge (FDA/EMA), data interpretation, strategic planning
Preferred skills
microbial controls, lean or six-sigma improvements, technical/scientific process engineering experience
Technologies
MES, ERP (SAP), LIMS, Quality Management Systems (TrackWise, Veeva)
Responsibilities
Lead QA shift team, oversee manufacturing batch records and logbooks, resolve complex manufacturing issues, coach and mentor operators and specialists, approve deviation records, drive continuous improvement initiatives, ensure psychological and physical safety
Seniority
Senior, hands-on IC with team leadership