M&S Graduate Program- IFB Quality Assurance Manager - Beijing
Core
Manage quality assurance for a new state-of-the-art, fully automated insulin drug substance manufacturing facility in Beijing, ensuring compliance with GMP and global standards during the greenfield project build.
Role type
Senior IC Quality Assurance Manager (Biopharma Manufacturing)
Builds
A new biologics manufacturing facility (Insulin Drug Substance) for commercial routine manufacturing
Domain
Biopharmaceuticals / Insulin Manufacturing / Greenfield Facility Construction
Required skills
Quality risk management, Quality systems, GxP compliance, Pharmaceutical manufacturing (automation), Regulatory knowledge (BLA process), Technical writing, Strategic planning
Preferred skills
MSc in Science/Pharmacy, FDA experience, International experience, Leadership, Cross-functional collaboration
Technologies
GxP, Quality Management Systems, Automation systems
Responsibilities
Ensure project execution aligns with Sanofi standards and Good Practices; Support development and implementation of quality management systems; Execute C&Q&V strategies and protocols (DQ, FAT, IQ, OQ, PQ); Track project costs and progress in quality assurance; Promote quality culture and GMP compliance; Act as Quality SME and mentor team members; Develop global quality documentation and procedures.
Seniority
Mid-Senior, hands-on IC with decision-making authority
