Director, Manufacturing Process & Technical Quality CGT

Job Description

General/Position Summary

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.

Key Duties & Responsibilities

Strategic Quality Execution

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.

Product Lifecycle Quality Leadership

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.

Operational Readiness & Manufacturing Support

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.

Quality Risk Compliance & Regulatory Leadership

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.

People & Organizational Leadership

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.

Required Education Level

Bachelors degree in life sciences biotechnology engineering or a related discipline.

Masters degree or equivalent relevant experience preferred.

Required Experience

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 or accountability for cross-functional teams and resource deployment.

Prior experience supporting a site program CMC or R&D leadership team strongly preferred.

Required Knowledge/Skills

In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (ICH/EU/FDA/etc.).

In depth experience in all stages of clinical product development to commercialization product life cycle management.

Direct experience with regulators (e.g. NDA BLA MAA submissions and/or inspections).

Broad technical knowledge in AAV/Cell technology aseptic processing process development manufacturing science & technology etc.

Ability to lead improvement projects - experience with Root Cause Analysis data analytics and other Operational Excellence experience such as LEAN DMAIC Six Sigma.

Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.

Ability to apply critical thinking and problem solving skills to decision making and operational priorities.

Strong leadership and an innate ability to mentor collaborate and build relationships

Demonstrated influential leadership experienced operating in a matrix organization through presenting influencing negotiation and partnering is required. Capable of building alignment across diverse perspectives and functional areas.

Other Requirements

Ability to travel domestically and internationally up to 25% as required

At Vertex we embrace continuous learning and encourage employees to stay informed on advances in AI technology automation and industry trends. We seek talent who bring an external perspective demonstrate curiosity and sound judgment and thoughtfully adopt new capabilities that improve decision-making drive innovation increase efficiency and help deliver better outcomes for patients.

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