Job Description
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us. Position Summary The Vice President, Cell Therapy Global Quality is accountable for development, deployment and execution of the Quality strategy for the Cell Therapy Development and Cell Therapy Operations organizations. The role is responsible for building, leading and optimizing the Quality organization throughout the global cell therapy network, including responsibility for: Patient Operations Quality Internal Manufacturing Quality External Manufacturing and Supply Chain Quality Global Product Quality, consisting of Development Quality, Product Lifecycle and CMC Quality Analytical Science and Technology Quality Systems & Compliance The role leads the Quality organization in the development, commercialization, supply, and lifecycle management of cell therapy products to meet clinical and commercial demand by ensuring effective quality systems, quality assurance, quality control and compliance processes through effective partnership across the broader Global Quality organization. This role is a member of the Global Quality Leadership Team and Cell Therapy Franchise Leadership Team. The role hires, trains, develops, and retains a large, highly skilled workforce; drives operational excellence to improve Quality and productivity; effectively implements new quality technologies, and creates an environment where our people will be engaged, grow, and thrive. Key Responsibilities The role is responsible for leading a large organization of site and above site Quality professionals globally, including Summit, NJ • Seattle, WA, Bothell, WA • Devens, MA • Warren, NJ • Leiden, NE • Boudry, CH, and Japan. The role covers end to end quality oversight of the cell therapy business operating unit, including process and analytical Development, Clinical Manufacturing and Commercial Manufacturing. In a highly complex, dynamic, nascent industry, this leadership role requires strong strategic and execution agility, a passion for operational excellence, a mindset for applying innovative improvements utilizing new technologies and advanced IT, and an ability to collaborate internally and externally to achieve the vision for becoming the world’s leading manufacturer of best-in-class cell therapies. Accountable for leading quality and compliance across the Cell Therapy organization, setting standards, and driving adherence to applicable cGMP regulations and company policies and procedures. Provides expert guidance to effectively address complex quality considerations associated with operating in a nascent field, including complex investigations, and sound decision making in a field where global regulations are still evolving. As a member of the Cell Therapy Leadership Team, champions and effectively engages cell therapy leadership in management responsibilities including: management reviews, annual product reviews, audits & inspections, data integrity, and GMP health authority reporting. Responsible for structuring the Cell Therapy Quality Organization to effectively meet quality, compliance and business objectives. Participates on executive steering committees overseeing external partnerships, collaborations and capital projects to ensure BMS is at the forefront of cell therapy quality; responsible for quality decisions in cell therapy governance committees. Accountable for Cell Therapy Tier 1 Quality Council metrics and leading Tier 2 Quality Council for the Cell Therapy organization Accountable for product quality lifecycle management and BLA approval enabling activities including authoring and approving quality related CMC documentation, pre-license approval inspection readiness. Responsible for development and deployment of global quality processes and systems enabling commercialization of cell therapy products. Sets quality and compliance goals and objectives for Cell Therapy Quality; establishes metrics to continuously monitor quality performance; ensures goals and objectives are effectively met Champions the development and