Quality Specialist

Responsibilities

• Manage and control the Quality system for GxP and health-regulated activities to ensure compliance with Sanofi standards and local regulations.
• Oversee GSP/GDP quality processes, including documentation management, records, and data integrity.
• Support regulatory inspections and continuous audit readiness for GSP/GDP processes.
• Manage deviations and Corrective-Preventive Actions (CAPA) related to all GxP activities.
• Implement change control management and risk assessment processes.
• Conduct self-inspections and manage quality oversight for local GxP subcontractors and distributors.
• Provide quality support for innovation, business initiatives, and digital transformation projects.
• Organize and manage GxP-related training programs for country associates.

Requirements

• 1-3 years of experience in the pharmaceutical industry, preferably in MNC GSP/GDP/GMP areas.
• Bachelor's degree or higher in Pharmacy, Medicine, Biology, Chemistry, or a related subject.
• Strong knowledge of GxP, GMP, and GDP regulations.
• Fluent in both Chinese and English (reading, speaking, and writing).
• Experience interacting with health authorities or industry associations.

Preferred Qualifications

• Experience in Quality Control (QC) for Bio-Pharm products.
• Licensed Pharmacist certification.

About the Company

Sanofi is a global healthcare leader dedicated to transforming the lives of patients through science. Our Manufacturing and Supply division focuses on delivering high-quality medicines and vaccines worldwide using state-of-the-art facilities and cutting-edge automation. We foster a culture of diversity, equity, and inclusion, empowering our teams to pursue progress and discover extraordinary solutions in healthcare.