Manager, QA Technical Operations

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. Position Summary BMS Cruiserath Biologics is seeking to recruit a Manager, QA Technical Operations, Drug Substance, on a fixed term basis. Reporting to the Senior Manager, QA Technical Operations, Drug Substance, the manager will support investigations within the Multi Product Cell Culture (MPCC) and supporting areas and act as the system owner for the Investigations process at site. The manager QA Technical Operations will also be responsible for supporting qualification and validation activities, as well as New Product Introductions (NPI) and technical transfers. The role will support Engineering, Warehouse, Facilities, Utilities and Automation activities while also providing support for SAP and Manufacturing Execution System (MES). The role will be both challenging & rewarding and will ensure that the successful candidate can seize a wide range of development opportunities within BMS. Key Responsibilities ·       Investigation system owner for the site with responsibility for MPCC, Warehouse, Automation, Engineering, Facility, Utility and Environmental Monitoring (EM) Investigations. ·       Manage the Investigation triage business process and the daily investigations meeting. ·       Support global harmonization of the investigations process through BMS network collaboration. ·       Act as investigation process SME during Health Authority inspections. ·       Act as QA Technical Operations Representative at Investigations Review Board (IRB) and Site Quality Council as required. ·       Quality Approver for local and complex multi-site investigations, deviations and subsequent CAPAs, and liaising with other sites/suppliers for complex investigations when required. ·       Site Representative at the Global investigations Community of Practice (COP) meetings and Local Process Owner (LPO) meetings. ·       Support Implementation of site initiatives to prevent deviation recurrence. ·       Promote Right First Time (RFT) approach within investigations process and drive accountability in meeting site investigation KPI’s. ·       Act as Senior Manager designee for QA huddles and at cross-functional meetings when required. ·       QA Lead for complex change controls, NPI and Tech Transfer Projects. ·       QA Lead for cross-functional projects at a site level and site QA representative on global projects. ·       Support the maintenance of Maximo, MES and SAP at BMS Cruiserath Biologics. ·       Support site validation and qualification activities. ·       QA review and approval of Annual Product Quality Review reports (APQRs) ·       Support the hiring, development and coaching of key members of the QA Technical Operations team. ·       Drive and support a culture of continuous improvement initiatives and safe working practices. ·       Review and approval of GMP documentation, including plans, protocols, reports, SOPs, forms, directives, policies and validation documentation as required. Qualifications & Experience The successful candidate must possess: ·       BSc in Science or a related discipline, with a minimum of 5 years Quality experience in the biopharmaceutical industry. ·       Demonstrated knowledge of applicable EU, FDA and other regulatory requirements. ·       A strong technical aptitude, global regulatory experience and demonstrated experience interfacing with regulators. ·       A thorough understanding of cGMP requirements for areas of responsibility. ·       Demonstrated in-depth knowledge of deviation and change management processes. ·       Required to work on his/her own initiative in addition to working as part of a team. Must be capable of working across a team matrix to meet accelerated timelines. ·       Capable of positively influencing others to bring resolution to complex issues. ·       Excellent communication and presentation skills are essential. ·       Excellent time management and organizational skills along with a proven ability to multi-task. ·       Demonstrated ability to recognise issues, highlight risks and prioritise workload based on site goals and objectives. ·       Excellent trouble shooting and problem solving skills as well as an ability to coach and mentor individuals or teams through complex problems. ·       Ability to challenge the status quo with a growth mindset. ·       Employees are expected to display the BMS values and behaviours, which enable them to be successful and perform at their highest level. 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 an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym #LI-Hybrid 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/ For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act. 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. R1608414 : Manager, QA Technical Operations