Sanofi
GlobalQualityThirdPartiesLeaderSingleUseSystemandBiologicalRawMaterial
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“Global Quality Third Parties Leader Single Use System and Biological Raw Material at Sanofi. Skills: Quality oversight and governance of third-party suppliers, Supplier quality performance management, Regulatory compliance, Risk mitigation, Cross-functional collaboration, Continuous improvement. Ensuring robust quality oversight and governance of third-party suppliers providing single-use systems and biological raw materials. Driving supplier quality performance, regulatory compliance, and risk ”
What You'll Achieve.
ensuring robust quality oversight and governance of third-party suppliers; driving supplier quality performance, regulatory compliance, and risk mitigation; directly supporting the continuity, safety, and integrity of Sanofi's biologics manufacturing
What They're Looking For.
Must Have
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., 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), English fluency required
Nice to Have
Veeva QTP knowledge is a plus.
What You'll Do.
Ensuring robust quality oversight and governance of third-party suppliers providing single-use systems and biological raw materials
Driving supplier quality performance
regulatory compliance
and maintaining the global quality strategy for third-party suppliers
Ensuring consistent application of quality standards across all supplier sites and geographies
Maintaining an up-to-date supplier portfolio and ensuring appropriate quality classification and tiering
Defining and monitoring supplier quality performance and driving corrective actions
Leading quality alerts and coordinating rapid response actions in case of critical supplier quality issues
Assessing supplier investigations and following up on CAPA implementation
and maintaining Quality Agreements
Overseeing the management of supplier-initiated changes impacting SUS and BRM quality
Assessing the impact of supplier changes on Quality Agreements
Coordinating the management of critical changes with internal key stakeholders
Acting as the primary quality interface between third-party suppliers and internal functions
Participating in cross-functional project teams
and reporting quality metrics related to third-party SUS and BRM performance
Leading and driving continuous improvement initiatives
Benchmarking industry best practices and implementing relevant improvements
How You'll Work.
Team & 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; Collaborate with Supply Chain and Procurement to identify alternative suppliers or mitigation strategies
Communication Scope
communication and active listening abilities; Act as Sanofi One Voice to supplier
Process & Methodology
experience in leading cross-functional projects, Project management expertise in international settings
Full Job Description
**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 Agreeme
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