Vice President, Cell Therapy Global Quality

Bristol Myers Squibb • Princeton, NJ

9h • Hybrid

About The Position

The Vice President, Cell Therapy Global Quality is accountable for the development, deployment, and execution of the Quality strategy for the Cell Therapy Development and Cell Therapy Operations organizations. This 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 (Development Quality, Product Lifecycle, and CMC Quality), and 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.

Requirements

• B.S. degree in relevant Science or Engineering.
• Advanced degree preferred (MBA, MS or PhD).
• Strong commercial bio/pharma manufacturing experience.
• Excellent people leadership expertise.
• Experience in Biologics or Cell/Gene Therapy manufacturing is required.
• 20+ years of relevant leadership experience in quality including site and above site quality leadership.
• Expertise in GxP and strong knowledge and experience with Health Authority inspections, notifications and interactions.
• Deep understanding of global regulatory requirements & guidelines to provide expert guidance.
• Proficient in quality management systems and technical expertise of biopharmaceutical manufacturing processes & technologies.
• Ability to interpret complex data and to make informed decisions.
• Experience with multiple quality and technical operations functions.
• Experience leading quality in multi-product manufacturing plants and leading across large matrix teams.
• Proven interpersonal and collaboration skills; communicates well orally and in writing.
• Experience in talent development, succession planning, and leadership development.
• Financial management experience, awareness, and strong business acumen.

Nice To Haves

• Advanced degree (MBA, MS or PhD)

Responsibilities

• Leading a large organization of site and above site Quality professionals globally.
• Providing end-to-end quality oversight of the cell therapy business operating unit, including process and analytical Development, Clinical Manufacturing and Commercial Manufacturing.
• Leading quality and compliance across the Cell Therapy organization, setting standards, and driving adherence to applicable cGMP regulations and company policies and procedures.
• Providing 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.
• Championing and effectively engaging cell therapy leadership in management responsibilities including: management reviews, annual product reviews, audits & inspections, data integrity, and GMP health authority reporting.
• Structuring the Cell Therapy Quality Organization to effectively meet quality, compliance, and business objectives.
• Participating 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, and pre-license approval inspection readiness.
• Responsible for development and deployment of global quality processes and systems enabling commercialization of cell therapy products.
• Setting quality and compliance goals and objectives for Cell Therapy Quality; establishing metrics to continuously monitor quality performance; ensuring goals and objectives are effectively met.
• Championing the development and implementation of innovative and digital solutions across the Cell Therapy Quality team and organization.
• Ensuring effective, compliant, and efficient quality processes and systems across cell therapy.
• Making quality and compliance decisions across the Cell Therapy Organization.
• Sponsoring quality and compliance harmonization, integration, and continuous improvement initiatives across cell therapy.
• Overseeing compliance audits and regulatory inspections by health authorities (e.g., FDA, EMA, PMDA, etc.), ensuring inspection readiness across cell therapy.
• Influencing and leading across the matrix in a highly matrixed environment, and working closely and collaboratively with BMS Global Quality, Legal, Cell Therapy Leadership Team, Cell Therapy Operations, Cell Therapy Supply Chain, Cell Therapy Regulatory, Clinical and Clinical Operations, Global MSAT, Cell Therapy Development, and Finance to achieve business goals.
• Leading the annual and 3YOP financial budgeting process for Cell Therapy Quality and ensuring adherence to budget.
• Driving external engagement and building relationships with global regulators to influence regulations in a nascent field.
• Coordinating and championing the effective deployment of new technologies and systems to improve quality, optimize productivity, reduce COGm, and reduce release times and deliver pipeline.
• Sponsoring project teams to plan and implement quality, technology, and business process improvements, along with integrated portfolio management.
• Developing workforce staffing strategies to achieve the rapid growth needed to meet the commercialization of products and pipeline.
• Building, developing, and leading an engaged workforce and driving a high-performance culture that is innovative, agile, open to change, and constantly learning in a high growth and evolving industry.
• Developing and maintaining a robust succession plan to ensure a pipeline of qualified candidates for key leadership positions.
• Mentoring and coaching emerging leaders, providing them with the guidance and opportunities needed to grow and succeed.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 5,001-10,000 employees