Director, Manufacturing Process & Technical Quality - CGT

The Director, Manufacturing Process & Technical Quality provides Quality leadership and end-to-end technical Quality oversight for assigned Cell & Genetic Therapies programs from development through commercialization and post-approval lifecycle management. The role is accountable for translating Quality strategy into compliant execution, establishing phase-appropriate product and process standards, identifying and mitigating Quality risks, and enabling operational and site readiness. Working across Development, Technical Operations, Manufacturing, Supply Chain, Regulatory, and external partners, the Director ensures alignment with the Vertex Quality Management System, global regulatory expectations, and business priorities.

• Translate program and CGT Quality strategy into compliant execution plans, priorities, and deliverables.
• Drive accountability for Quality decisions, issue resolution, escalation, and delivery of commitments.
• Ensure compliance with the Vertex Quality Management System, global GxP requirements, procedures, and regulatory commitments.
• Influence stakeholders and foster a culture of Quality, operational discipline, and continuous improvement.

• Provide end-to-end Quality oversight from development through commercialization and post-approval lifecycle management.
• Define phase-appropriate product, process, analytical, and control strategy expectations.
• Serve as the Quality lead for technical transfer, comparability, PPQ, validation, regulatory submissions, launch, and lifecycle activities.
• Integrate Quality requirements into program plans, governance, stage-gate deliverables, and product-impact decisions.

• Lead Quality readiness for process scale-up, technology and analytical transfer, PPQ, launch, and commercial operations.
• Assess site capabilities, Quality systems, operational controls, training, documentation, and inspection readiness.
• Establish readiness plans, milestones, governance, and escalation processes to identify and close gaps.
• Drive sustainable remediation, process robustness, right-first-time execution, and reliable supply across internal and external sites.

• Identify, assess, communicate, and mitigate product, process, compliance, and supply risks.
• Represent Quality in program, technical, site, and change-control governance, providing independent, risk-based recommendations.
• Ensure appropriate oversight and escalation of significant deviations, OOS results, CAPAs, changes, and emerging trends.
• Support health authority inspections, regulatory interactions, commitments, and implementation of evolving regulatory expectations.

• Lead, coach, and develop team members, with clear priorities, performance expectations, and accountability for results.
• Build the technical and Quality capabilities required to support portfolio progression and commercialization.
• Prioritize and deploy resources across business objectives, delivery commitments, compliance requirements, and risks.
• Manage assigned budgets, external support, and resource plans in alignment with approved business priorities.

• Bachelor's degree in life sciences, biotechnology, engineering, or a related discipline.
• Master's degree or equivalent relevant experience preferred.

• Typically requires 10+ years of progressive experience in Quality, manufacturing, technical operations, development, or Quality Control within the biotechnology or pharmaceutical industry.
• At least 3 years of leadership experience, including direct people leadership…