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 MaterialLocation: Framingham, MAAbout 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.About SanofiWe 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 ResponsibilitiesGlobal Quality Oversight & GovernanceDefine, implement, and maintain the global quality strategy for third-party suppliers of single-use systems and biological raw materialsEnsure consistent application of quality standards across all supplier sites and geographiesMaintain an up-to-date supplier portfolio and ensure appropriate quality classification and tieringDefine and monitor supplier quality performance and drive corrective actions where performance gaps are identifiedTP AlertLead quality AlertCoordinate rapid response actions in case of critical supplier quality issues impacting manufacturingAssess supplier investigation and follow up CAPA implementationWhen relevant, Collaborate with Supply Chain and Procurement to identify alternative suppliers or mitigation strategies while maintaining quality standardsQuality AgreementsNegotiate, draft, review, and maintain Quality Agreements with third-party SUS and BRM suppliersChange notificationsOversee the management of supplier-initiated changes (change notifications) impacting SUS and BRM qualityAssess 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 CollaborationAct as the primary quality interface between third-party suppliers and internal functions including Manufacturing, Procurement, R&D, Regulatory Affairs, and Supply ChainParticipate in cross-functional project teams for new product introductions, technology transfers, and process changes involving SUS or BRMContinuous Improvement & Quality MetricsDefine, track, and report quality metrics related to third-party SUS and BRM performanceLead and drive continuous improvement initiatives to enhance supplier quality systems and processesBenchmark industry best practices in SUS and BRM quality management and implement relevant improvementAbout YouBasic QualificationsMasters 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 abilitiesProject 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 requiredWhy 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 its 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 andwellness 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 scaleTransform 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.#GD-SP#vhdAll 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.