Executive Director Quality, Cell & Gene Therapy

Executive Director, Cell & Genetic Therapies Quality

The Executive Director serves as a strategic leader responsible for defining and executing the Cell & Genetic Therapies (CGT) Quality vision, operating model, and organizational strategy. The role is accountable for ensuring quality readiness from early development through commercialization while building scalable, inspection-ready quality capabilities across internal manufacturing sites and external partner networks. The position drives enterprise CGT quality leadership, digital innovation, talent development, and risk-based decision making to support the successful delivery of life-changing therapies to patients.

The role includes partnering with internal stakeholders to build & coordinate a phase appropriate quality roadmap to commercialization.

Key

Duties & Responsibilities:

Strategic Leadership Expectations

• Define and execute the long-term CGT Quality strategy aligned with Vertex corporate objectives.
• Build scalable quality operating models to support portfolio growth and global commercialization.
• Serve as a member of the CGT governance operating model and contribute to business, network and program, decisions.
• Drive enterprise-wide quality transformation initiatives.
• Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning for the delivery of business & financial goals.

Manufacturing and Technical Development Quality

• Lead and represent Quality in Cell & Genetic Programs and serve as a trusted partner to establish the roadmap for innovative therapeutic programs. Uses an understanding of early CGT drug development processes, relevant late-stage challenges, and global regulatory requirements to support advancement of CGT programs to meet quality compliance requirements.
• Partner with functional stakeholders to support strategy and health authority requests from investigational medicine to market authorization submissions in support of timely submissions and approvals
• Partner to execute quality oversight for process and analytical technical transfers as part of product life cycle development.
• Lead the development and execution of CGT quality & technical risk management including execution of associated mitigation plans to successfully bring CGT programs to commercialization.
• Drive the development of an integrated digital quality, to build and establish capabilities supporting proactive quality management and operational decision-making.

Commercialization and Launch Quality Accountability

• Accountable for quality readiness of CGT assets through commercialization and lifecycle management.
• Establish quality strategies supporting launch readiness, product lifecycle management, and global market expansion.
• Lead quality governance for PPQ, process validation, comparability, and commercial readiness activities.
• In support of program advancement to commercialization, develops the quality road map to commercial operational readiness.

Quality Oversight Internal & External

• Establishment of quality oversight for internal quality and external CRO/CMO operations, from early development to commercial stage including manufacturing and distribution of product globally.
• Executive sponsor for health authority inspections and regulatory interactions.
• Lead the CGT quality team to continuously manage, assess and drive operational excellence & compliance drug product manufacture of internal manufacturing sites as well as oversight of external partners.
• Provides quality leadership to proactively establish best practices based on emerging trends, and projection of future regulatory requirements.

People Leadership

• Build and develop a high-performing global quality organization.
• Establish succession planning and talent development strategies.
• Foster an inclusive culture focused on accountability, innovation, collaboration and continuous improvement.
• Lead and mentor other team members, support development of organizational capabilities and talent building.
• Accountable for annual operating budgets, resource planning, organizational design, and strategic investments supporting CGT Quality operations.

Required Education Level:

• Master's degree or PhD in Biotechnical/Lifescience discipline or relevant comparable background.

Required Experience:

15+ years of quality/technical experience in pharmaceutical development and commercial manufacture,

10+ years in a management/supervisory role.

Required Knowledge/

Skills:

• In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
• Broad and deep technical and compliance expertise in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
• Current knowledge of industry trends and best practices in Cell/Gene therapies.
• Proven expertise / experience with strategies for gene- and cell therapy products, regulatory documentation preparation and…