About the JobAs Quality Compliance Head for Manufacturing Supply Specialty Care GBU, you will provide critical oversight of cGMP compliance across our network. You'll support sites in inspection readiness, manage health authority interactions, and assess implementation of Sanofi's Quality Management Systems in accordance with company and regulatory requirements.You will lead cGMP Regulatory Compliance projects through transversal activities across our site network. This role serves as a vital link between Site Quality Units, the MS SpeCare GBU Quality Unit, and Global Operational Quality Units.Key ResponsibilitiesLead cGMP compliance projects aligned with MS SpeCare GBU Quality Operations strategySupport inspection readiness through quality system assessments and gap identificationGuide external inspection preparation, management, and health authority responsesReview effectiveness of sites' Quality Systems during visits and interactionsContribute to Global Quality Dashboard reporting for management visibilityCoordinate IRISC activities for the MS SpeCare GBUChampion quality culture and continuous improvement across all organizational levelsSupport training initiatives on Sanofi Global Quality System and regulatory requirementsFacilitate knowledge sharing through webinars and best practice exchangesProvide quality risk management support and contribute to Risk Management ReportsParticipate in digital transformation initiatives aligned with Global Quality strategyCollaborate with quality experts across GBUs and global quality functionsAbout YouExperience:Advanced knowledge of pharmaceutical and medical device regulationsIn-depth experience of Biologics OperationsDeep experience in interacting with health authorities (FDA, ANSM)sound knowledge/experience in BiologicsEducation:Pharmacy degree or equivalentMaster's Degree in Pharmaceutical Technology, Life Sciences or EngineeringLanguages:Fluent in Englishadditional French language knowledge welcome – but not a mustTechnical Skills:Regulatory expertiseProject management proficiencyStrong analytical capabilitiesQuality Risk Management experienceContinuous improvement methodologiesKnowledge in digital tools and new technologiesSoft Skills:Business partnering and stakeholder managementExcellent communication and networking abilitiesInfluential and change-oriented mindsetCustomer-focused approachTransversal collaborationResults-driven with decision-making capabilitiesStrategic thinkingLocation: Gentilly, France or Frankfurt, GermanyWork Arrangement: up to 40% Remote working optionTravel: 20% expectedPosition Type: Permanent, Full-timePursue Progress. Discover Extraordinary.Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!null
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