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. Act as Vendor Quality Manager (VQM) for the assigned contract service providers (e.g. distributors, wholesalers or marketing partners), ensuring GDP/GMP compliance. Responsabilities Management of Quality Logistics issues / deviation management Change management / CAPA Ensure GDP compliance for vendor relevant processes Ensure QAg (Quality agreements) with vendors and related h-Celgene and/or h-BMS entities are updated as per corporate standards Quality support during business review meetings with vendors (partnership with MSO function) Contribute to GDP/GMP audit preparations. Support audit execution as appropriate (Due diligences) & technical visits (changes, new vendors…) Responsible for annual vendor assessments Quality responsible for GMP - Redressing operations & local manipulations under responsibility (this might include approval of master protocols, review executed documentation, handle related deviations, changes etc.) Return management. Handling product returns and quality assessment of disposition. May approve as deputy of QP/RP of h-Celgene and/or h-BMS Distribution Quality Prepares trending of Deviations/CAPA and Quality compliance performance (KPI) for Distribution CSPs Supports/leads quality risk assessments projects within supply chain area Support validation /qualification of supply lane routes Ensure transport operations in the region comply with applicable GDP requirements Partners with relevant h-Celgene and/or h-BMS QA affiliates (and/or central function in charge of oversight of affiliates) to understand local GDP regulations and ensure compliance. Support the execution of mock recall exercise. Collaborate/coordinate recalls as assigned. Collaborate on logistics investigations, product inventory reconciliation/gathering distribution data to support any quality issue/query (e.g. Product quality complaints or deviations / Quality logistics issues) Act as SME (Subject Matter Expert) in Health Authority inspections for different h-Celgene and/or h-BMS entities (affiliates, manufacturing sites, etc.) for GDP processes (returns, recall, distribution, transport, etc.) Can deputize/act as back-up of other Distribution Quality positions (regional responsible managers and global). E.g. Trainings, Quality management system updates, shipment studies, Redeployments & Returns, etc. Perform/support self-inspection program of h-Celgene and/or h-BMS Distribution Quality Actively monitor & review with management quality relevant performance indicators for Distribution operations in the region: monthly KPIs / Quality Management Reviews / Quality Councils data Can act/engaged as quality liaison for projects with GDP/GMP impact on the region (e.g. business change of distribution model etc.) Required Skills BSc/MSc within Science / Engineering / Medical Field Fluent in English and French (not mandatory) At least seven (7) years of experience in Quality Assurance and/or Logistics/Supply Chain in a pharmaceutical company or other related industry Thorough understanding of cGDPs and applicable GMP Extensive knowledge and experience in pharmaceutical health care operations, distribution and International regulations are essential. Proficient in GDPs and/or cGMPs regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001:2000 regulations; and requirements for pharmaceutical products distribution Excellent interpersonal, collaborative and organizational skills Works independently, yet effectively in a team environment Ability to focus attention to details Excellent written & oral communication skills Knowledge of most common office software (Microsoft Office) 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.