Expert, Quality Operations, External Manufacturing Management

About the role

Sanofi is seeking an Expert in Quality Operations to manage external manufacturing activities. The role will serve as the quality focal point for a portfolio of Contract Manufacturing Organizations (CMOs) and suppliers, ensuring compliance with GxP, regulatory requirements, and internal standards.

Key responsibilities

• Act as the quality contact for assigned CMO/supplier portfolio, monitor quality KPIs and lead annual quality evaluations.
• Manage quality events from receipt to closure, conduct investigations, implement CAPA, and assess batch disposition decisions.
• Evaluate change requests for quality impact, regulatory compliance, and supply continuity; participate in Change Control committees.
• Oversee audit follow‑up, CAPA completion, sterility assurance reviews, and approve serialization go‑live agreements.
• Review and approve Product Quality Reviews (PQR) and manage documentation such as SAP Quality Information Records (QIR) and Bills of Materials (BOM).
• Drive continuous improvement projects and support divestment processes.

Required profile

• 5‑8 years of professional experience in pharmaceutical quality assurance, including work at manufacturing or distribution sites.
• Demonstrated experience managing quality oversight for CMOs or external suppliers.
• Strong understanding of GxP regulations, CAPA processes, and change control procedures.

Required skills

• SAP (Quality Information Records, Bill of Materials)
• GxP compliance
• CAPA management
• Change Control expertise
• Product Quality Review (PQR) preparation
• Serialization processes