Associate Director, Shift Quality Operations (Onsite)
Core
Advanced technical resource providing shift-based quality leadership and oversight for aseptic cell therapy manufacturing operations to ensure cGMP compliance and safe production.
Role type
Senior IC quality operations leader (cell therapy)
Builds
Safe, compliant, and efficient aseptic manufacturing batches for cell therapy products
Domain
Biotechnology / Regulated pharmaceutical manufacturing (cell therapy)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP regulations, aseptic processing principles, contamination control strategy, deviation/CAPA/investigation systems, batch record review, risk management, root cause analysis, data analytics, LEAN, DMAIC, Six Sigma
Preferred skills
Master's degree, people leadership/supervisory experience, commercial or late-stage clinical manufacturing environment experience
Technologies
MES, LIMS, eQMS, data visualization tools, advanced analytics
Responsibilities
Provide shift-based QA oversight for aseptic manufacturing operations, lead deviation triage and investigation, coach and develop a team of shift quality professionals, maintain inspection readiness for aseptic areas, partner with cross-functional teams on production schedule and process improvements
Seniority
Senior, hands-on IC with team leadership