Manager, External Quality Vaccines - Asia
Core
Oversees quality assurance activities for late-phase clinical programs and commercial vaccine launches, ensuring compliance with QMS and cGMP across multiple Contract Manufacturing Organizations (CMOs) and global markets.
Role type
Manager, Quality Assurance (Vaccines)
Builds
Compliant vaccine manufacturing and distribution processes
Domain
Pharmaceuticals / Biologics / Vaccines
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) oversight, cGMP compliance, deviation and investigation management, change control management, batch record and test record review, validation documentation review, technology transfer support, regulatory audit support, CAPA management, document lifecycle management
Preferred skills
Experience with global regulatory authorities, risk mitigation, continuous improvement initiatives
Technologies
Office software packages, specialized QA software applications
Responsibilities
Conduct investigations on GMP & GDP related issues, review and approve manufacturing deviations and out-of-specification results, support change management at interface with CMOs, review and approve batch production and test records, perform batch disposition, execute Person in Plant QA oversight, manage document life cycle of GMP related documents, support technology transfer and validation of manufacturing processes, support regulatory or global audits
Seniority
Manager, strategic oversight & operational execution
