Executive Director Quality, Cell & Gene Therapy

## Executive Director Quality, Cell & Gene Therapy Apply locations:
Boston, MAtime type:
Full time posted on:
Posted Todayjob requisition :
REQ-29691
** Job Description
***
* Position Summary:

** 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,…