Associate Director, Quality Operations – Bristol Myers Squibb – Boudry, NE

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.


Responsabilities:

  • Proactively manage Third Party Manufacturer and Alliance Partnership relationships from a quality and compliance perspective
  • Develop and manage the quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships
  • Actively support the BMS Fact Finding (FF) and Product Review Committee (PRC) processes for major investigations involving Third Party products. Prepare and present the information to senior management in support of the FF/PRC processes
  • Provide quality/compliance subject matter expertise to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MS&T 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/CMC and the local country-based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions etc.
  • Manage the quality metrics programs in relation to Contract Manufacturing Organization and VPT performance
  • Serve as the Quality Operations leader in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties
  • Prepare, negotiate and approve Quality Agreements with the Third Party Manufacturers and Alliance Partners
  • Review and approve the Annual Product Quality Reviews submitted by the Third Party Manufacturers
  • Support the Global BMS external auditing program by participation in audits of Third Parties as requested
  • Select and retain Quality employees on VPTs
  • Allocate resources such that the right person is doing the right work at the right time
  • Review and approve goals and objectives for direct reports
  • Proactively develop and mentor staff


Required Competencies:

  • In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
  • Ability to assess the right balance between business targets and scientific and quality decisions
  • Ability to build relationships, partnerships and influence and/or enforce quality decisions at external manufacturers
  • Strong negotiation, communication and presentation skills across all levels both internal and external to BMS
  • Strong analytical and problem-solving skills


Required Qualifications:

  • BSc or equivalent in scientific discipline
  • Five to ten years’ experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency
  • Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
  • Direct experience interacting with Health Authorities and managing Health Authority inspections, specifically FDA and/or EMA
  • Direct experience in interacting with external manufacturers and managing quality at external manufacturing sites
  • The Qualified Person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products

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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