Executive Director Quality, Cell & Gene Therapy

Vertex Inc.•Boston, MA

1d•$244,800 - $367,200•Onsite

About The Position

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.

Requirements

Master's degree or PhD in Biotechnical/Lifescience discipline or relevant comparable background.
15+ years of quality/technical experience in pharmaceutical development and commercial manufacture,
10+ years in a management/supervisory role.
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 inspections.
Demonstrated strategic planning and execution skills required for operational effectiveness and compliance.
Demonstrated leadership supporting late-stage development, commercialization, and marketed products.
Significant experience leading quality organizations across global manufacturing networks and external partners.
Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
Ability to apply risk management principles to decision making and operational priorities.
Critical Thinking and Problem-Solving skills.

Responsibilities

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.
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.
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.
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.
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.