Head of Quality Assurance Operation Unit (APU) & Sterility

Responsibilities

• Assist the site quality head in ensuring products are manufactured and controlled under cGMP conditions and marketing authorization.
• Develop and update the quality management system and SOPs in alignment with local cGMP, industry standards, and Sanofi requirements.
• Ensure cGMP compliance for calibration, utilities, systems, production processes, and control procedures.
• Make critical decisions regarding batches, materials, and quality events in compliance with registered specifications.
• Provide quality assurance oversight through routine inspections of production, laboratory, warehouse, and engineering areas.
• Manage deviations and Out of Specification (OOS) results, monitoring CAPA to prevent recurrence.
• Act as the final evaluator for change controls related to sterile and non-sterile manufacturing.
• Lead sterility assurance by establishing robust contamination control strategies and providing technical expertise on clean zone optimization and environmental monitoring.
• Manage the QA team, including performance management, individual development plans, and technical training.
• Oversee quality system management for CMOs when the Beijing site acts as the MAH.

Requirements

• 5+ years of experience in Quality Control (QC) and/or Quality Assurance (QA).
• 3+ years of experience in a management position.
• 3+ years of experience in sterility assurance and microbiological control within the pharmaceutical, biotechnology, or medical device industry.
• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Strong knowledge of analytical chemistry and microbiology.
• Fluency in English (both verbal and written).
• Proven leadership skills with the ability to think strategically and make decisive actions under pressure.

About the Company

Sanofi is a global healthcare leader dedicated to transforming scientific breakthroughs into life-changing medicines and vaccines. Our Manufacturing & Supply division bridges the gap between research and patients, utilizing state-of-the-art facilities and cutting-edge automation to deliver high-quality treatments worldwide.