Senior Director Cell & Genetic Therapies Quality Personalized Medicine

Job Description

General/Position Summary

The Senior Director CGT Quality Systems Personalized Medicine provides strategic Quality leadership for personalized medicine and advanced cell therapies across the patient journey. The role is accountable for advancing Quality oversight governance compliance and continuous improvement while ensuring efficient patient-centric process across the end to end patient journey.

This highly cross-functional position requires strong matrix leadership and partnership with Global Quality and Manufacturing MS&T Regulatory Commercial and Supply Chain stakeholders. Success requires the ability to influence enterprise decisions build strong partnerships and drive alignment through executive presence and effective communication. The ability to balance long-term vision with flawless execution of complex business and quality priorities is key for the position.

Key Duties & Responsibilities

Leadership Strategy & Organizational Capabilities

• Provide strategic Quality Systems leadership in support of personalized medicine /advanced CGT programs ensuring alignment with CGT Business Objectives Vertex Global Quality Strategy commercial priorities regulatory expectations and patient-centered outcomes.
• Define prioritize and execute the CGT Quality Systems across clinical launch and commercial lifecycle stages.
• Partner with stakeholders to ensure effective risk management resolution and mitigation plans are identified established and executed.
• Lead mentor and develop team members; build organizational capability and foster accountability collaboration innovation and operational excellence.
• Leverage technical and Quality expertise across CGT QA to resolve critical challenges drive timely decision-making and ensure effective communication and escalation of risks constraints and commitments.
• Create and foster a culture of collaboration quality excellence continuous improvement transparency and accountability across Quality and partner functions.
• Responsible for leading and participating in key CMC Quality initiatives to advance and mature Vertexs Global Quality Systems.

• Provide End to End compliance oversight for personalized medicine/advanced CGT internal and external quality operations ensuring quality remains compliant with applicable enterprise Vertex Global Quality procedural requirements and global regulations.
• Establish compliance governance routines to proactively monitor compliance trends operational performance and emerging risks that may impact product quality patient safety supply continuity or program execution; lead or support risk-based mitigation plans continuous improvement actions and sustainable process enhancements.
• Partner with digital stakeholders to ensure CGT user requirements are embedded in lifecycle management projects from design through implementation including sustainment.
• Support inspection readiness and audit-related activities in relation to Quality CGT oversight.

• Lead and provide Quality oversight across the end to end patient CGT treatment journey assuring GMP requests are assessed governed documented escalated and resolved in a timely compliant risk-based and patient-centric manner.
• Chair or support cross-functional review of GMP related patient treatment journey requests including requests involving patient-specific constraints.
• Ensure Quality Management Review Boards are executed in line with Global Quality System requirements when quality or compliance impact is identified across the patient treatment journey.

• Partner with Global Quality and cross-functional stakeholders to support development and deployment of advanced digital reporting solutions and use of artificial intelligence in CGT to enable transparent governance decision-making and escalation of quality and operational risks.
• Improve compliance and strengthen proactive quality management efficiency data integrity and processes maturity and scalability across CGT investigations change controls risk assessments CAPA and management review.

Required Education Level

• Bachelors or Masters degree in engineering life sciences pharmaceutical sciences or related technical discipline required.

Required Experience

15 years of experience and 7 years in a management/supervisory role or the equivalent combination of education and experience in a regulated pharmaceutical environment

Required Knowledge/Skills

• Broad experience in quality and compliance oversight for allogeneic/autologous cell manufacturing processes or other personalized medicine modalities from development through commercial lifecycle.
• In-depth knowledge of global health authority expectations and GxP requirements across the lifecycle for cell and gene therapy biologics and advanced therapy products.
• Enterprise Impact & Influence with the ability to shape decisions across the organization through strong partnerships communication and executive presence.
• Balance long-term vision with operational excellence driving quality transformation while ensuring compliance and patient-focused outcomes.
• Ability to apply risk management principles critical Thinking and Problem Solving skills

Other Requirements

• 15% travel

#LI-hybrid #LI-JS1

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at