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 Vertex’s  Global Quality Systems.

Quality Systems & Compliance Oversight for Advanced CGT Personalized Medicine

• 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.

Patient Treatment Journey Quality 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.

Analytics, Data Integrity & Continuous Improvement

• 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

• Bachelor's or Master's 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 Vertex’s 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 person's 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 [email protected]