Manager QA, Clinical Supply Chain Quality

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The position is within the Supply Chain In Market Quality (SCIMQ) organisation that is responsible for the oversight of CSC Quality activities including CSC Logistics EMEA/ASIA PAC operations. The position is responsible for the Quality of Supply Chain related activities including but not limited to processes such as Use Date Extensions, ISR studies, IMP supply and management at sites & third party logistics risk management. This position provides leadership for the identification and resolution of critical quality issues that may affect BMS Support start-up activities for Clinical Supply Chain Quality Dublin, including but not limited to: Review and approval of QA related procedures Support preparation and approval of training materials Support review and approval of Quality Agreements Ensure knowledge transfer from current release site Support Manufacturer(s)/Importation Authorisation and Wholesale Distribution Authorisation submissions as required Support regulatory inspections in the capacity of subject matter expert and host, as applicable Support sustaining operations, including but not limited to: Compiles Qualified Person batch release dossiers Supports Packaging & Labeling activities performed at EUWH. Provides Quality Assurance support in the Use Date Extension process. Provides Quality Assurance support (GMP/GDP guidance and training) for CSO Regional Logistics. Support in a timely manner, the investigations of non-conformances and quality incidents. Resolves and documents into Quality Management System deviations or problems pertaining to the review of documents. Conducts appropriate follow-up as required. Tracks deviation, investigations and CAPAs. Authors ISR related Quality agreements, keeps agreements current and manages updates required. Prepares release dossiers for ISRs Prepares and reviews procedural documents as requested by supervisor. Support preparation of training materials. Delivers training on QA processes. Contribute to improving and maintaining CSCQ QMS Monitors Product Specification File (PSF) for upcoming release. Prepare and approve supply chain flow maps, and product specification files. Review and prepare updates for Manufacturer(s)/Importation Authorisation. Provides quality support on process improvement projects in PDQ. Authoring, review, and approval of QA-related procedures Supporting generation of/updates existing Quality Agreements. Adherence to BMS core behaviors Act as delegate for Senior Manager, QA. Some responsibilities of the Manager QA may be delegated to Senior Specialist, QA where deemed necessary and appropriately Why you should apply You will help patients in their fight against serious diseases You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days of annual leave , access to BMS Cruiserath on-site gym and life assurance We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway. How We Work Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account. R1605760 : Manager QA, Clinical Supply Chain Quality