M&S-China EM&S Quality Head-Shanghai

Role Summary

Role: M&S-China EM&S Quality Head in Shanghai. Lead the quality management and regulatory compliance framework for EM&S China products, ensuring alignment with NMPA GMP requirements and biologics manufacturing standards. Build and manage a biologics-focused quality team and oversee technology transfer, CMO relationships, and product dossiers to support regulatory registrations and ongoing compliance.

Responsibilities

• Quality Management System: Define, implement & maintain Quality Management Systems for EM&S China products; ensure compliance with NMPA GMP requirements, China volume-based procurement policies, and Sanofi GOPs; manage local regulatory requirements specific to China's biologics manufacturing regulations; oversee implementation of quality systems for large molecule manufacturing.
• CMO Oversight: Perform risk ranking for CMOs per Sanofi Directive with emphasis on biologics capabilities; monitor CMO compliance with China's NMPA requirements and biologics standards; identify and mitigate CMO-related risks; track CMO performance through KPIs.
• Quality Agreement: Establish Quality Agreements between Sanofi and CMOs incorporating China-specific requirements; ensure agreements address biological product manufacturing requirements.
• Technology Transfer: Manage technology transfers including small and large molecules and biological products; ensure compliance with NMPA technology transfer guidelines; oversee analytical method transfers.
• Regulatory Compliance & Regulatory Projects: Maintain regulatory status at External Manufacturing sites per NMPA guidelines; handle regulatory queries for chemical and biological products; stay current with evolving NMPA regulations and procurement policies; support CMO selection and due diligence for new partnerships in China; evaluate technical capabilities of potential CMOs.
• Product Dossier Management: Manage product dossiers according to NMPA requirements; ensure compliance with Chinese regulations; oversee product registration requirements.
• Team Management: Build and lead a qualified quality team with biologics expertise; ensure team development in both small and large molecule quality oversight; provide technical guidance on biological product quality matters.

Qualifications

• B.Pharm/ M.Pharm / Ph.D/ MS/ MSc in relevant field
• 15-20 years total experience in the Pharmaceutical Industry
• Minimum 10 years in Quality Function with demonstrated experience in biologics
• At least 5 years' experience managing quality systems for large molecules and/or biological products in China
• Experience with NMPA inspections and regulatory interactions
• Proven track record of successful CMO management in China

Knowledge, Skills & Competencies

• Expert knowledge of NMPA regulations and guidelines, particularly for biological products
• In-depth understanding of biologics manufacturing and quality control processes
• Experience with biological product technology transfers
• Native-level Mandarin Chinese proficiency (written and spoken)
• Excellent English communication skills
• Strong leadership and stakeholder management capabilities