Quality und Regulatory Affairs Specialist (m/w/d)

61348 Bad Homburg

We have a clear commitment: putting best-possible solutions in the hands of medical profes sionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. Bad Homburg / Hessen · Permanent · Full-time · As of now ~(Senior) Manager (m/f/d) Supplier Compliance Management Packaging (Quality Expert) Are you ready to play a pivotal role in ensuring the quality and compliance of Fresenius Kabi's packaging materials suppliers? Fresenius Kabi is seeking a dedicated Manager for Supplier Compliance Management (Quality Assurance) in Packaging. This global position offers a unique opportunity to collaborate across borders and ensure safety and compliance of Fresenius Kabi's lifesaving medicines. Collaborate with internal teams (Quality Management, Sourcing, Regulatory Affairs) and external partners (suppliers) to ensure seamless supplier compliance & quality management for packaging materials. Establish and maintain quality agreements with suppliers and verify compliance with Fresenius Kabi's stringent quality standards. Lead the corporate supplier evaluation process, engage in performance reviews with suppliers, and define targeted development initiatives where necessary. Manage global packaging material changes. Coordinate closely with Operations Units, Innovation & Development and Regulatory Affairs functions to establish an efficient change control process for supplier changes and support the implementation of improvement at Fresenius Kabi. Support the selection and qualification of new and alternative packaging suppliers from a quality assurance perspective. Academic background in (Packaging) Engineering, natural sciences, pharmacy or a technical discipline, accompanied by at least 2 years of experience in quality or primary packaging roles within the healthcare sector. Extensive knowledge of GxP standards for packaging (e.g., ISOand expertise in quality assurance within pharmaceutical or medical industries. Solid understanding of regulatory registration procedures across Europe, the US, and China, ensuring compliance on a global scale. Familiarity with packaging production techniques, such as glass and stopper manufacturing, thermoplastics, or label printing processes. Business fluency in English and German, with adept IT skills (MS Office, SharePoint, SAP) and an open-minded, target-oriented mindset. Join us and make a meaningful impact on healthcare packaging at Fresenius Kabi. Fresenius Kabi Deutschland GmbH Quality Management Full-time Fresenius Kabi Deutschland GmbH Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. With 140 hospitals and numerous outpatient facilities, Fresenius Helios is the leading private hospital operator in Germany and Spain, treating around 26 million patients each year. Fresenius Kabi's product portfolio includes a range of highly complex biopharmaceuticals, clinical nutrition, medical devices and generic intravenous drugs, serving 450 million people annually. T20:59:59Z FULL_TIME
Eine Stellenanzeige von Joobel

Fresenius Kabi Deutschland GmbH

61348 Bad Homburg

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