Senior Manager, Quality Assurance Shop Floor 2nd Shift
Core
Senior leader ensuring quality standards and compliance for cGMP Cell Therapy manufacturing, release testing, and packaging operations on the shop floor.
Role type
Senior Manager, Quality Assurance Shop Floor
Builds
Autologous drug products via manufacturing, release testing, and packaging
Domain
Biopharmaceuticals / Cell Therapy / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, quality management systems, deviation/CAPA management, cross-functional leadership, strategic decision-making, regulatory knowledge (FDA/EMA), technical writing
Preferred skills
aseptic/sterile environment experience, microbial controls, lean/six-sigma, process engineering background, Master's degree in STEM/MBA
Technologies
MES, ERP (SAP), LIMS, Quality Management Systems (TrackWise, Veeva)
Responsibilities
Lead and mentor night-shift managers; oversee on-floor quality oversight and triage of unexpected events; serve as subject matter expert for quality management system issues; approve deviation records; coach and develop staff; champion safety and continuous improvement culture; represent QA in governance forums and audits.
Seniority
Senior Manager, hands-on leadership
