Senior Manager, ExM Quality

Job content

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Working in a cross-functional virtual plant team this senior quality operations manager provides quality oversight of Contract Manufacturing Organizations (CMOs) through effective collaboration with the other VPT functions. Primary responsibility is to support management of CMO disposition documentation, assure CMO compliance with BMS and applicable cGMP and international regulatory standards for biologics drug substance and biologic/sterile (parenteral) drug product manufacture, testing, and distribution.Responsibilities

• In collaboration with Responsible Person and Qualified Person perform product disposition activities to ensure the timely supply of drug substance, drug product, and finished biological products
• Serve as a quality lead for the technical CMO projects related to commercial BMS product
• Own or provide quality evaluation and approval of the change controls related to commercial biological products from CMOs
• Provide quality decision on the deviations reported by CMOs for manufactured BMS products. Lead deviation meetings with CMOs.
• Prepare and review of Quality Agreements with external and internal manufacturing and testing partners
• Manage and report quality metrics in relation to CMO performance
• Review and collaborate with CMO and BMS sites on Annual Product Quality Reviews as required for end-to-end product monitoring
• Work with CMOs to ensure commercialization and PAI readiness for biological products introduced to CMOs
• Review and approve analytical documentation in collaboration with the analytical SME
• Provide quality operational support during self-inspections, internal audits, and regulatory agency inspections at contract manufacturers and BMS.
• Support supplier relationship manager, global procurement, supply chain and manufacturing science and technology teams for the projects, technical transfers programs, supplier selection programs, and commercial manufacturing activities
• Review validation documents, deviations, and change controls and escalate any potential compliance gaps
• Escalate issues to senior management to ensure that issues are resolved to support BMS business and compliance requirements in a timely manner
• Evaluate external quality complaint investigations provided by CMOs

Required Competencies

• Minimum B.S. degree in relevant scientific discipline e.g., Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
• Minimum of 6 years’ experience in aseptic or sterile manufacturing operations at the manufacturing site (manufacturing department, quality assurance and release, or manufacturing science/technology)
• At least 4 years in Quality Assurance, ideally in project management or product release
• Experience in biological product manufacturing
• Experience in contract manufacturing
• Good verbal, written and presentation skills in English
• Experience with complex technical writing, ideally with authoring investigations, quality risk assessments, process descriptions, or study protocols
• Ability to assess the right balance between the business implications, technical considerations and quality decisions
• Ability to set up and implement quality expectations for technical projects based on regulatory and industry standards
• Ability to serve as a quality lead for technical projects
• Strong negotiation, communication and presentation skills across all levels both internal and external to BMS
• Demonstrated technical expertise in resolution of deviations, complaints, development of effective corrective and preventive actins (CAPA) and use of risk assessments
• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while assuring that all cGMP and regulatory requirements are met
• Excellent verbal, written and presentation skills in English
• Proficiency with the use of global systems (e.g. SAP, Microsoft Office).
• Strong strategic and analytical thinking, problem solving and rapid decision making skills

Additional Desired Qualifications/experiences

• Ability to negotiate and clearly present complex topics both in written and verbally
• Knowledge of combination products manufacturing or finished drug product packaging
• Experience with Packaging Operations
• Experience with GMP tools and standard applications: SAP, Trackwise or Verity, MS Office (esp. OneNote, Visio)
• Good knowledge of German (allowing for the review of technical documentation – Specific to certain roles)
• Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous environment
• Confidence in negotiating and influencing without authority
• Proficiency in technical writing

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.