Budapest, HUN
11 hours ago
Senior CMC Material & Documentation Flow Manager
+ _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 **Senior CMC Material & Documentation Flow Platform Manager** and you’ll support the efficient coordination of Drug Product (DP) and Marketed Product (MP) receipt and transfer, supporting our clinical and non-clinical development projects. **Main responsibilities:** 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_** **Experience:** + Minimum 2-3 years’ experience in pharma supply chain, CMC, clinical field or pharma R&D + Knowledge of Pharma/ Clinical Supply Chain processes and deliverables + GMP certification/ experience is a plus **Knowledge, soft skills and competencies:** + Excellent oral and written communication skills + Ability to work productively with a broad and diverse group of stakeholders + Ability to prioritize tasks and multitask/ agile mindset **Technical skills:** + Strong knowledge of ERP systems + Digital skills **Education:** + Minimum Bachelor of Science (BS) degree **Languages:** + Excellent written and verbal communication skills in English **_Why choose us?_** + Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment + Work from an "Office of the Year 2023" award winner with flexible home office policy + 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 and wellness programs and at least 14 weeks’ gender-neutral parental leave + An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks + Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs) 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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together. Discover our Code of Conduct (https://www.codeofconduct.sanofi/) , that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying. \#Sanofi #SanofiCareers #joinSanofi \#jobopportunities #careeropportunities #sscjob \#Sanofi_Budapest_Hub #Budapest \#R&D #CMC #GMP #supplychain #materialmanagement #documentation \#LI-EUR #LI-hybrid **Pursue** **_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, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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