M&S-Country Quality Supervisor-Shanghai
Core
Manage the Country Quality Management System for GxP activities from development to commercialization, ensuring compliance with Sanofi and local regulatory requirements in Shanghai.
Role type
Senior IC Quality Supervisor (Pharmaceuticals/Healthcare)
Builds
GxP compliant quality systems, documentation, and processes for product lifecycle management.
Domain
Healthcare / Pharmaceuticals / GxP / Regulatory Compliance
Required skills
GxP system management, regulatory compliance, quality audit execution, CAPA management, change control, risk management, document lifecycle management, data integrity, quality training, product complaint handling, recall coordination, validation management, MAH/MAHD regulation implementation.
Preferred skills
Knowledge of China GxP regulations, digital tools for quality operations, stakeholder management across global and local functions.
Technologies
Global content management systems, Global Quality computerised systems, digital properties inventory tools.
Responsibilities
Implement and control the Country Quality Management System; oversee GxP operations and compliance (PV, regulatory, supply chain); manage GxP documents and records ensuring data integrity; conduct local quality audits and support regulatory inspections; manage deviations, CAPAs, and change controls; monitor quality KPIs; handle product complaints, inquiries, and recalls; implement quality risk management; ensure personnel qualification and training; manage validation processes; support China MAH/MAHD post-market obligations.
Seniority
Senior, hands-on IC
