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Bristol Myers Squibb

Sr Director, External Manufacturing, Quality Systems and Strategy (R1558524-en-us)

Manufacturing and Production

Manufacturing Engineer

Yearly

No

New Brunswick, New Jersey, United States

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.

The Senior Director, ExM Network Quality, Strategy, Systems & Technical Support will support the VP, External Manufacturing Quality and have direct linkage to the GMQ Executive Director, Quality Management, Strategy & Network Support to define, shape and drive the Global ExM Quality Strategy, provide quality systems and network technical support, and ensure network interconnectivity across the enterprise.

Role Responsibilities:

  • Facilitates creation of the Global ExM Quality strategy in concert with ExM Quality Leadership Team (QLT) and the GMQ ED, Quality Management, Strategy, and Network Support. Ensures evolution of strategy based on business and market needs on, at least an annual basis.

  • Facilitates creation of ExM Quality tactical objectives with the ExM QLT and work in concert with ExM Operations and GMQ Quality Management, Strategy and Network on GMQ and Network shared objectives.

  • Works closely with the GMQ Support function to monitor performance objectives, monitor the ExM Quality budget and ensure linkage of the ExM Quality Project Governance program with the broader GMQ Quality Project Governance program.

  • Ensures that the organization has a Continuous Improvement mindset and culture and actively seeks objectives to evolve processes, systems, and development of colleagues.

  • Responsible for Management of the day-to-day activities associated with the Quality Systems in scope of ExM Quality inclusive of Product Quality Complaints, Deviations, CAPAs, APQRs, Training Management, and Quality Risk Management.

  • Ensures ExM Quality is fully aligned with external regulations, GMQ and the BMS Quality Management Systems (QMS).

  • Ownership, oversight and implementation of Quality Systems across the Global ExM network in concern with GMQ Quality & Compliance Excellence.

  • Supports audits, Health Authority inspections and associated logistics when required, including the assistance in the generation of HA Responses and CAPAs.

  • Manages, and coordinates the GMP Tier 3 Quality Council(s) to manage Contract Manufacturing Organization (CMO) compliance and supply risks. Manages the governance of the Tier 3 Quality Council(s) and ensures linkage with the GMP Tier 2 Quality Council and expectations of the GMQ Quality & Compliance Excellence function.

  • Ensures linkage to the GMP Tier 2 Quality Council in concert with the GMQ Support function and analyzes the ExM Quality KPIs, raising potential risks along with risk mitigation activities/proposals to the appropriate Tier Quality Council.

  • Leads the ExM Technical Compliance organization for Global ExM Operations, consisting of CMC/Regulatory Compliance and Analytical Compliance components.

  • Ensures CMC/Regulatory Compliance for Active and Intermediates, Bio/Sterile, and Non-Sterile/Packaging operations, including oversight of change management and product restrictions to control disposition of products subject to change approval.

  • Ensures ExM Quality has the required network interconnectivities and interdependence with the GMQ Support function(s) to ensure alignment with the GQ vision.

  • Leads communication in line with the GMQ Support function and the ExM QLT and develops strategies & partnership with stakeholders from MS&T, OPEX, Supply Chain, Regulatory, Project Management, and ExM Operations.

  • Creates global, Single Points of Contact (SPOC) for initiatives, activities and sister organizations (e.g. Operations, MS&T, Procurement, S&BO).

  • Actively interfaces with “End-to-End” GQ organization (e.g. GMQ, Global Quality Systems, Regulatory Compliance & External Engagement, etc.) to ensure alignment and consistency in the GXP throughout ExM Quality, Global Quality Initiatives, and Quality Systems management.

Role Requirements:

  • Advanced degree in science of pharmaceutical related fields (Chemistry, Pharmacy, Biology, and Chemical Engineering) preferred.

  • Minimum of 10 years of Biopharmaceutical experience in commercial manufacturing environments.

  • Knows and understands Quality compliance processes and regulations, e.g. cGMP/GDP regulations.

  • Thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality investigations.

  • Thorough understanding of technical areas related to pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes.

  • Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end-to-end enterprise) and makes the best decisions for the whole.

  • Excellent influencing and negotiating experience and capabilities in a matrix environment. Must be able to interact with senior leaders in this capacity and as such is seen as a highly regarded and a credible leader with the ability to act on behalf of the VP EXM Quality and interface with stakeholders in a matrix environment.

  • Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.

  • Strong project management and execution skills and can manage multiple projects and prioritize as needed. Ability to plan and conduct projects within a multi-disciplinary environment.

#LI-Hybrid

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.