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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. Ensures GMP compliance within Manufacturing by owning documentation, quality events, risk assessments, and inspection readiness activities. The role supports deviation management, change control and audit responses while contributing to defect library training and Communities of Practice. Through hands‑on execution and collaboration, the position supports continuous improvement and sustained regulatory compliance. Duties/Responsibilities GMP Manufacturing Documentation & Training • Author and maintain manufacturing GMP documentation, including SOPs, forms, and logbooks • Act as document owner, ensuring lifecycle management and compliance Manufacturing Quality Events & Compliance Processes • Initiate and own activities from initiation to closure for: • Actions coming form the QMS (e.g. CAPA, Proactive initiatives, standalone actions, Supplemental Actions, Change Action...) • Change Controls • Findings arising from self-inspections • Quality event without root cause analysis • Initiate and own deviations from creation through deviation assessment • Participate to deviation investigation when needed • Initiate Supplier Corrective Action Requests (SCARs) • Participate to Communities of Practice (CoPs) Risk Management • Own, perform, and maintain risk assessments, including: • Manufacturing Risk Assessments • Data Integrity Risk Assessments (DIRA) and associated summary reports Defect library • Participate to staff training to the defect library Audit & Inspection Readiness • Act as Manufacturing SPoC for inspection readiness, • Actively contribute to manufacturing inspection-readiness • Continue to responses coming from audit observations and inspection findings Continuous Improvement • Support local continuous improvement initiatives related to compliance, process effectiveness, and inspection readiness • This job description is not intended to be exhaustive; additional duties and responsibilities may be assigned as needed to meet business requirement. Qualifications • Bachelor’s degree in Life Sciences or related field • 3-5 years in GMP compliance • Good collaboration and communication skills • 3-5 years of experience in pharmaceutical environement • Business Level in French and English • Experience in GMP inspections and audits 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. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [email protected] . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1604260 : Senior Specialist Compliance Process Excellence, Commercial Operations