Manager, Shop Floor Quality Assurance, Cell Therapy
Core
Lead a shift team of 4-8 specialists to ensure 24/7 quality oversight and compliance in a Cell Therapy manufacturing facility.
Role type
Senior IC Manager, Shop Floor Quality Assurance
Builds
Manufacturing batch records, deviation/CAPA management, and quality oversight for cell therapy products
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, deviation and CAPA management, aseptic/sterile environment operations, FDA/EMA regulatory knowledge, team leadership, batch record review, quality risk management
Preferred skills
microbial controls, lean or six-sigma improvements, technical/scientific process engineering
Technologies
MES, ERP (SAP), LIMS, Quality Management Systems (TrackWise, Veeva)
Responsibilities
Lead walkthroughs to identify and remediate operational or quality issues; Interview, hire, coach, motivate, and develop exceptional staff; Proactively identify and address quality risks and critical issues; Provide direction and timely guidance to QA shift-managers regarding cGMP events; Independently approve deviation records within the quality management system
Seniority
Manager, hands-on IC