Quality Management & Compliance • Ensure quality culture, mindset, GMP compliance performance, and continuous improvement across all functions and organizational levels in the project and future sites. • Serve as Quality Subject Matter Expert (SME) for the project on all matters related to Quality Management system. • Deliver Quality activities in accordance with IFB planning & project needs, including writing, reviewing, and releasing documentation as required. • Lead the development, implementation, and assurance of Quality Management Systems. • Support raw material workstream and TPM to ensure quality compliance according to relevant Sanofi global quality standard and local regulations. • Develop, update, and promote Sanofi Global Quality Documentation, GOPs or Global procedures. Communication & Reporting: • Actively engage in project team meetings, planning sessions, and related project requirements to ensure effective planning and execution of key Quality Assurance deliverables. • Ensure that the project is executed in accordance with Sanofi standards and Good Practices. • Report on key project deliverables related to Quality Assurance, ensuring timely and effective communication and escalation of quality issues to the appropriate levels of management. • Contribute to the Digital strategy and transformation through appropriate communication within the project. • Collaborate with the facilities within Sanofi to maintain benchmark standards and share best practices. • Provides regular reporting to the IFB Quality Lead. Project Execution & Validation • Support execution of project C&Q&V strategy, plans, and System impact assessment. • Ensure the consistency of turnover packages to system owners. • Support the review/approval of validation protocols and final reports. Project Control, Costs & Schedule: • Supports the regular tracking of actual project costs and progress. • Supports compliance with Sanofi guidelines and standards for cost and scheduling.

Experience • Degree in Science/Pharmacy or Equivalent. • Ideally MSc level qualification in Science. • 3-5 years industry experience, preferably within the biopharma and/or related regulated industry. • In-depth knowledge of the biologic product license application process, and the associated regulatory requirements. • Experience: Practical experience in Quality System Management in Health regulated industry. • Knowledge & experience in Pharmaceutical Manufacturing with production processing including automation. • Experience in scientific and technical writing • Experience in CapEx project execution and project quality management is a plus. • Effective oral and written communication skills, and innovative thinking. Soft Skills: • Driving change • Cross-functional collaboration • Decision-making • People development • Negotiation and influencing skills • Business partnering • Communication skills • Leadership and assertiveness Technical Skills: • Quality Management Systems • Continuous improvement management • Project management • GxP and health-regulated requirements. Languages: • Chinese(fluent, both written and spoken) • English (fluent, both written and spoken)