Position Summary
The Senior Manager Compliance, MFG Compliance & Support reports to the Associate Director, MFG Compliance & Support. This role is part of the overall manufacturing organization and accountable to manage the Manufacturing Compliance & Support operations activities. The Senior Manager Compliance is accountable for the contributions that directly support Manufacturing quality compliance, review board representation, and manufacturing inspection readiness. This role is responsible, in collaboration with Manufacturing management, to manage Manufacturing deviations, CAPAs, CCs, quality KPI adherence, inspection readiness, MFG business continuity, and Aseptic Process Simulation program. The Senior Manager Compliance leads a team of specialists that will work in a matrix organization to deliver on full C&S scope. The Senior Manager Compliance is expected to collaborate with other C&S managers to organize and allocate the specialists to meet business demands.