Global Quality Third Parties Leader Single Use System and Biological Raw Material

About the role

Within our Global Quality Third parties team, Global Quality Third Parties Leader -Single Use System (SUS) and Biological Raw Material (BRM) is responsible for ensuring robust quality oversight and governance of third-party suppliers providing single-use systems and biological raw materials critical to Sanofi's biopharmaceutical manufacturing operations. This strategic role drives supplier quality performance, regulatory compliance, and risk mitigation across a global supply base, directly supporting the continuity, safety, and integrity of Sanofi's biologics manufacturing.

Main Responsibilities

• Define, implement, and maintain the global quality strategy for third-party suppliers of single-use systems and biological raw materials
• Ensure consistent application of quality standards across all supplier sites and geographies
• Maintain an up-to-date supplier portfolio and ensure appropriate quality classification and tiering
• Define and monitor supplier quality performance and drive corrective actions where performance gaps are identified
• Lead quality Alert
• Coordinate rapid response actions in case of critical supplier quality issues impacting manufacturing
• Assess supplier investigation and follow up CAPA implementation
• When relevant, Collaborate with Supply Chain and Procurement to identify alternative suppliers or mitigation strategies while maintaining quality standards
• Negotiate, draft, review, and maintain Quality Agreements with third-party SUS and BRM suppliers
• Oversee the management of supplier-initiated changes (change notifications) impacting SUS and BRM quality
• Avoid assessing the impact of TOP supplier changes on Quality Agreement, Audits needs, QSMP, and QMS database and drive appropriate changes action
• Coordinate the management of critical changes with internal key stakeholders. Act as Sanofi One Voice to supplier
• Act as the primary quality interface between third-party suppliers and internal functions including Manufacturing, Procurement, R&D, Regulatory Affairs, and Supply Chain
• Participate in cross-functional project teams for new product introductions, technology transfers, and process changes involving SUS or BRM
• Define, track, and report quality metrics related to third-party SUS and BRM performance
• Lead and drive continuous improvement initiatives to enhance supplier quality systems and processes
• Benchmark industry best practices in SUS and BRM quality management and implement relevant improvement

About You

• Master’s degree in Engineering or science discipline or related fields
• 10+ years of experience in Manufacturing operations, Quality positions within the pharmaceutical environment or any related fields
• Knowledge of QTP processes, experience in leading cross-functional projects
• Proven ability to work cross-functionally in complex, matrix environments
• Strong communication and active listening abilities
• Project management expertise in international settings
• Technical understanding of biopharmaceutical manufacturing systems
• Demonstrated open-mindedness and agility (challenge status-quo)
• Veeva QTP knowledge is a plus
• Languages: English fluency required

About Sanofi

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.