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 your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
  
  

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.