Vice President, Cell Therapy Global Quality

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 implementation of innovative and digital solutions across the Cell Therapy Quality team and organization.
• Ensures effective, compliant and efficient quality processes and systems across cell therapy.
• Makes quality and compliance decisions across the Cell Therapy Organization.
• Sponsors quality and compliance harmonization, integration and continuous improvement initiatives across cell therapy.
• Oversees compliance audits and regulatory inspections by health authorities (e.g., FDA, EMA, PMDA, etc.), ensures inspection readiness across cell therapy
• Working in a highly matrixed environment so must influence and lead across the matrix, and work closely & 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.
• Leads annual and 3YOP financial budgeting process for Cell Therapy Quality and ensures adherence to budget
• Drives external engagement and builds relationships with global regulators to influence regulations in a nascent field.
• Coordinate and champion the effective deployment of new technologies and systems to improve quality, optimize productivity, reduce COGm, and reduce release times and deliver pipeline.
• Sponsor project teams to plan and implement quality, technology, and business process improvements, along with integrated portfolio management. 
• Develop workforce staffing strategies to achieve the rapid growth needed to meet the commercialization of products and pipeline.
• Build, develop and lead an engaged workforce and drive a high-performance culture that is innovative, agile, open to change, and constantly learning in a high growth and evolving industry.
• Develop and maintain a robust succession plan to ensure a pipeline of qualified candidates for key leadership positions.
• Mentor and coach emerging leaders, providing them with the guidance and opportunities needed to grow and succeed.

General and Leadership

• Ownership & Decisiveness: Critical thinking and structured problem solving in support of risk-based decision making in a nascent space. Takes the long view, and when faced with challenging obstacles, always exemplifies doing what is in the best interest of patients. Conveys a sense of urgency and drives issues to closure. Makes timely decisions when a quick response is required and ensures evaluation of several options when needed.
• Engaging Leadership in a Matrix Environment: Effectively lead and oversee large organization and influence cross-functional global teams without direct authority.
• Communication & Collaboration:  Ability to collaborate with interdependent teams, R&D, manufacturing, regulatory affairs, and supply chain. 
• Resilience & Agility:  Can easily rebound from setbacks when facing difficult situations, flex or pivot quickly in a highly complex, fast-paced environment
• Talent and People Development: Creates and maintains an environment where employees are fully engaged, willing to speak up and can develop and thrive.
• BMS Values: embraces the company Values of Integrity, Passion, Inclusion, Innovation, Urgency, and Accountability.
• Integrity and Compliance: Embodies a compliance, quality and continuous improvement mindset.

Qualifications & Experience

• B.S. degree in relevant Science or Engineering. Advanced degree preferred (MBA, MS or PhD)
• Strong commercial bio/pharma manufacturing experience, and 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.

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