M&S Graduate Program- IFB Quality Assurance Manager - Beijing
Core
Lead quality assurance for a new state-of-the-art, fully automated biologics facility manufacturing insulin in Beijing, ensuring compliance with GMP and global standards.
Role type
Quality Assurance Manager for a greenfield biopharma manufacturing project
Builds
A new automated insulin drug substance manufacturing facility
Domain
Biopharmaceuticals / Insulin Manufacturing / GxP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing facility setup)
Required skills
Quality risk management, Quality systems, GxP compliance, Pharmaceutical manufacturing knowledge, Scientific and technical writing, Strategic planning, Risk analysis
Preferred skills
MSc level qualification, International and FDA experience, Automation knowledge
Technologies
None explicitly listed as tools/frameworks
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), Conduct quality oversight and documentation review, Mentor project team members on quality compliance, Report on project costs and progress regarding quality, Promote quality culture and continuous improvement
Seniority
Mid-level Manager (3-5 years experience)