Define, implement & maintain Quality Management Systems for EM&S China products, ensuring compliance with NMPA GMP requirements, China volume-based procurement policies, and Sanofi GOPs
Job Summary
Define, implement & maintain Quality Management Systems for EM&S China products, ensuring compliance with NMPA GMP requirements, China volume-based procurement policies, and Sanofi GOPs.
Manage technology transfers including small molecules, large molecules and biological products, ensuring compliance with NMPA technology transfer guidelines.
Build and lead a qualified quality team with biologics expertise, ensuring team development in both small and large molecule quality oversight.
Matching Summary
Define, implement & maintain Quality Management Systems for EM&S China products, ensuring compliance with NMPA GMP requirements, China volume-based procurement policies, and Sanofi GOPs.
Skills & Requirements
Must-have
NMPA GMP requirements
biologics manufacturing regulations
CMO compliance monitoring
Quality Agreements
technology transfers
product dossier management
regulatory compliance
Nice-to-have
innovative global healthcare company
supportive, future-focused team
endless opportunities to grow
thoughtful, well-crafted rewards package
Key Requirements
15-20 years total experience
Minimum 10 years in Quality Function
At least 5 years' experience managing quality systems for large molecules and /or biological products in China
Native-level Mandarin Chinese proficiency
B.Pharm/ M.Pharm / Ph.D/ MS/ MSc in relevant field