Sanofi
GlobalQualityThirdPartiesLeaderSingleUseSystemandBiologicalRawMaterial
“Global Quality Third Parties Leader Single Use System and Biological Raw Material at Sanofi. Skills: Quality oversight, Governance, Supplier management, Risk mitigation, 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 mitigation”
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; enhance supplier quality systems and processes
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 investigation and following up CAPA implementation
Collaborating with Supply Chain and Procurement to identify alternative suppliers or mitigation strategies
and maintaining Quality Agreements with third-party SUS and BRM suppliers
Overseeing the management of supplier-initiated changes impacting SUS and BRM quality
Assessing the impact of supplier changes on Quality Agreement
Coordinating the management of critical changes with internal key stakeholders
Acting as Sanofi One Voice to supplier
and reporting quality metrics related to third-party SUS and BRM performance
Leading and driving continuous improvement initiatives to enhance supplier quality systems and processes
Benchmarking industry best practices in SUS and BRM quality management 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; Coordinate the management of critical changes with internal key stakeholders
Communication Scope
communication and active listening abilities
Process & Methodology
leading cross-functional projects, Project management expertise in international settings
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