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Senior Manager - Quality Operations

Inseriert am: 27.05.2021

Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied. Key accountabilities Support the coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships Actively support the Bristol Myers Squibb (BMS) Fact Finding (FF) and Product Review Committee (PRC) processes for major investigations involving Third Party products Provide quality/compliance support to the wider Supplier Relationship Management, Global Procurement, Supply Chain and Manufacturing Technology (MT) teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs, etc. Provide the requisite quality support to Global BMS functional groups such as Global Regulatory/Chemistry, Manufacturing and Controls (CMC) and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions, etc. Coordinate quality metrics programs in relation to Third Party performance Provide support to Quality Operations Management Team in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties Assist in the preparation of Quality Agreements with the Third Party Manufacturers and Alliance Partners Review the Annual Product Reviews submitted by the Third Party Manufacturers Support the Global BMS external auditing program by participation in audits of Third Parties as requested Provide support to specified quality and technical projects as they arise Skills and knowledge Strong communication and presentation skills across all levels both internal and external to BMS A BSc in a scientific discipline such as Chemistry or Microbiology Significant experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency Experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables first-hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development Ideally will have experience in interacting with Health Authorities and supporting Health Authority inspections Direct experience in interfacing with external manufacturers In depth knowledge of current Good Manufacturing Practices (cGMP) regulations pertinent to the United States of America (USA), European Union (EU) and other international markets Ability to develop cross-functional and external working relationships Proven analytical and problem solving skills Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor. Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.


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