Head of Quality Assurance Operations (Drug Product)
Core
Lead the Drug Product Quality Assurance team to oversee quality of sterile drug product manufacturing (Formulation, Filling, Inspection, Packaging, Release, Distribution) and final batch release at the Sanofi Swiftwater Site.
Role type
Senior leadership IC Head of Quality Assurance Operations
Builds
High-quality life-saving vaccines and sterile drug products for global distribution
Domain
Biopharmaceuticals / Sterile Drug Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, sterile/aseptic manufacturing oversight, batch disposition management, CAPA/deviation handling, root cause analysis, team leadership, regulatory inspection readiness, KPI monitoring
Preferred skills
ASQ certification, CQE certification, Six Sigma
Technologies
RABS, Isolators, Microsoft Excel, Microsoft PowerPoint, Microsoft Word
Responsibilities
Lead the QA Drug Product Ecosystem and manage a team of QA Operational Managers; oversee batch review and disposition for intermediates and finished goods; develop and implement annual QA operation objectives and procedures; ensure timely closure of quality events (deviations, CAPAs, change controls); monitor KPIs for team performance and manufacturing quality metrics; drive continuous improvement initiatives and technology adoption; lead management reviews and cross-functional collaboration with Regulatory Affairs and Supply Chain.
Seniority
Senior, hands-on IC with people leadership
