Live Virus Vaccine Quality Operations Lead
Core
Lead quality systems, GMP compliance, and risk management for live virus vaccine formulation and filling operations across a global manufacturing network.
Role type
Senior IC Quality Operations Lead (Associate Director level)
Builds
Compliant, reliable supply of live virus vaccines for patients globally
Domain
Biopharmaceuticals / Vaccines / cGMP
Required skills
cGMP compliance, GMP regulations, CAPA management, deviation management, risk management, change control, master batch records, aseptic handling, leadership, cross-functional collaboration, regulatory inspection readiness
Preferred skills
LSS Green Belt certification, lean processing, talent management, multi-project management, sterile processing experience, vaccine manufacturing experience
Technologies
QMS, Master Batch Records, Change Control Systems, Risk Management Tools
Responsibilities
Lead quality system functions to ensure GMP compliance; manage and coach a team of Quality Specialists; oversee vaccine formulation and filling operations; review and approve deviations, CAPAs, and change requests; partner with Operations to ensure product compliance; participate in regulatory inspections and governance committees.
Seniority
Senior, hands-on IC with management responsibilities