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

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

• Location: Framingham, MA

About the Job

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.

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.

Main Responsibilities

Global Quality Oversight & Governance

• 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

TP Alert

• 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

Quality Agreements

• Negotiate, draft, review, and maintain Quality Agreements with third-party SUS and BRM suppliers

Change notifications

• Oversee the management of supplier-initiated changes (change notifications) impacting SUS and BRM quality

• Assess 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.

Cross-Functional Collaboration

• 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

Continuous Improvement & Quality Metrics

• 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

Basic Qualifications

• 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

Why choose us?

•  Bring the miracles of science to life alongside a supportive, future-focused team. 

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. 

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 

• Take good care of yourself and