Jobs / Hungary / Sanofi US Services INC
Team Leader and Senior CMC Material and Documentation Flow Manager
Sanofi US Services INC · 🌍 Budapest
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About the role
• Location: Budapest, Hungary • Job type: Permanent, full-time • Hybrid working About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Join our global CMC Integrated Demand & Supply Planning team as a Team Leader and Senior CMC Material & Documentation Flow Manager and you’ll have two main missions: Team Leader (20%): As solid line manager to the CMC material & Documentation Flow Managers: • Act as liaison for team members and go-to person for all administrative and P&C relevant topics • Conduct individual development discussions and compensation cycles As dotted line manager of the CMC Demand & Supply global organization: • Closely collaborate on the onboarding and training of newcomers to ensure timely and quality delivery of assigned tasks • Contribute to measuring team and individual performance through defined KPIs • Develop resource capacity as needed to align with the workload assigned Senior CMC Material & Documentation Flow Manager (80%): • Support CMC Integrated Demand and Supply team in the management of material and documentation requirements for product flows (DP or MP) under the accountability and supervision of / and the timelines defined by Demand & Supply Leader assigned to a given project. • Provide daily support for the efficient coordination of Drug Product (DP) and Marketed Products (MP) receipt and transfer in the context of clinical and non-clinical development by execution of Material Flow Management (MFM) services: • Create and maintain material codes in ERP systems • Execute ERP transactions (Purchase Orders and Transfers Orders) • Coordinate Drug product transfer from manufacturing facilities to packaging facilities • Oversee Drug Product (DP) flow management for Contract Manufacturing Organization (CMO) Packaging • Coordinate and execute Drug Product destruction plans • Serving as Subject Matter Expert (SME) for Qualipso and provide technical support for Qualipso events management (including CMO/FSO) (e.g., temperature excursion management, deviation handling) • Filling product documents such as Product Information Document (PID), Drug Product Study Document (DPSD), Traceability reports, Technical Conditions for DP shipments • Filling products data in D&S tools such as COMPASS, Demand Module (DMM), RDPM • Request of product documents to the appropriate owners as prerequisites for DP handling such as TOR, quarantine and shipment authorization, CoR/CoA, US customs documentation, preparation and tracking of French Import License request form • Provide customs documentation expertise and support in documentation management in compliance with regulatory requirements, e.g., US customs documentation, CN customs requirements definition and French Import License request form preparation and tracking • Support operational planning activities by providing DP schedule information to CSC Operations warehouse About you Education / Experience : • Bachelor of Science (BS) degree, or ideally Master’s degree or equivalent with at least 3-5 years’ experience in pharmaceutical industry with experiences in supply chain, CMC, and/or clinical fields • GMP certification is a plus Technical skills & Competencies : • Inspiring manager with strategic thinking