Senior Director Cell & Genetic Therapies Quality - Personalized Medicine

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Vertex Pharmaceuticals in Boston seeks a Senior Director, CGT Quality Systems to lead quality governance for personalized medicine and advanced cell therapies, ensuring patient-centric, compliant operations across the end-to-end journey.

You will partner across Global Quality, Manufacturing, Regulatory, Commercial and Supply Chain to align strategy, drive continuous improvement, and enable timely decisions with executive presence.

Qualifications

• 15+ years of experience in regulated pharmaceutical environments.
• 7+ years in a management or supervisory role.
• Deep knowledge of CGT and cell therapy quality systems.
• Experience with global health authority expectations and GxP across lifecycle.

Responsibilities

• Provide strategic Quality Systems leadership for CGT programs across clinical, launch, and commercial lifecycle stages.
• Define, prioritize, and execute the CGT Quality Systems across clinical, launch, and commercial lifecycle stages.
• Partner with stakeholders to ensure effective risk management and timely mitigation plans.
• Lead, mentor, and develop team members; foster accountability and collaboration.
• Support inspection readiness and audit activities in relation to Quality CGT oversight.

Skills

Quality leadership

Regulatory compliance

GxP knowledge

CGT/Cell therapy

Risk management

Cross-functional leadership

Education

Bachelor's or Master's in engineering, life sciences or pharmaceutical sciences

Job description

Job Description

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.

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