Job Title: Global Quality Third Parties Leader Single Use System and Biological Raw Material
About the JobWithin 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 ResponsibilitiesGlobal 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
The salary range for this position is:
$133.500,00 - $192.833,33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
