Team Leader and Senior CMC Material & Documentation Flow Manager
Hely: Budapest
Cég: Sanofi
Kategória: Szállítás, Beszerzés, Logisztika
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 topicsConduct individual development discussions and compensation cyclesAs 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 tasksContribute to measuring team and individual performance through defined KPIsDevelop resource capacity as needed to align with the workload assignedSenior 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) servicesCoordinate and execute Drug Product destruction plansServing 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 shipmentsFilling products data in D&S tools such as COMPASS, Demand Module (DMM), RDPMRequest 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 formProvide 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 trackingSupport operational planning activities by providing DP schedule information to CSC Operations warehouse 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 fieldsGMP certification is a plusTechnical skills & Competencies : Inspiring manager with strategic thinkingAbility to develop people, build a talent pipeline, and serve as a role modelCritical thinking and ability to challenge the team and oneselfStrong knowledge of the pharmaceutical landscapeStrong knowledge of CMC and Clinical Supply Chain processes and systemsProject Management skills, with the ability to prioritize, adapt to evolving demands, think pragmatically, and solve problemsDigital skills and strong appetite to work with multiple toolsExcellent oral and written communication skillsAbility to work collaboratively and productively with multicultural groups of stakeholdersLanguage(s): Proficiency in written and spoken English is required to interact with multiple stakeholders worldwide Bring the miracles of science to life alongside a supportive, future-focused team in an international work environmentWork from an "Office of the Year 2025" award winner with flexible home office policyEnjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impactTake good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leaveAn individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeksJoin a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)
Címkék: Employee status, College
profession.hu - kb. 7 órája
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