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.
Perform risk ranking for CMOs, monitor their compliance with China's NMPA requirements and biologics manufacturing standards, and establish Quality Agreements incorporating China-specific requirements.
Build and lead a qualified quality team with biologics expertise, ensuring team development in both small and large molecule quality oversight and providing technical guidance on biological product quality matters.
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 oversight and risk management
Quality Agreements
Technology Transfer management
Product Dossier Management
Regulatory Compliance
Team Leadership
Nice-to-have
innovative global healthcare company
flourish and grow your career
supportive, future-focused team
endless opportunities to grow talent
thoughtful, well-crafted rewards package
health and wellbeing benefits
gender-neutral parental leave
Key Requirements
15-20 years total experience
Minimum 10 years in Quality Function
Minimum 5 years managing quality systems for large molecules/biological products in China
Native-level Mandarin Chinese proficiency
Excellent English communication skills
B.Pharm/ M.Pharm / Ph.D/ MS/ MSc in relevant field