Director, Manufacturing Process & Technical Quality - CGT

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 185,000 - 277,000; Full time

Benefits offered by this job

Medical benefits

Dental/ Vision

401(k) matching

Education assistance

Paid time off

Job summary

Vertex Pharmaceuticals Inc is seeking a Director, Manufacturing Process & Technical Quality to provide leadership across CGT quality from development to commercialization. You will mentor teams, ensure GxP compliance, and drive readiness for scale-up, technology transfer, and regulatory submissions.

You will lead issue resolution, CAPA governance, and risk management while partnering with Development, Technical Operations, Manufacturing, Supply Chain, and Regulatory to ensure Vertex Quality

Qualifications

• Bachelor's degree in life sciences, biotechnology, engineering or related field; master's preferred.
• 10+ years in Quality, manufacturing, technical operations within biotech/pharma; 3+ years leadership.
• In-depth global regulatory GXP knowledge across CGT/Biologics; direct regulator interaction experience.

Responsibilities

• Provide end-to-end Quality oversight from development through commercialization and post-approval lifecycle management.
• Lead Quality readiness for process scale-up, technology transfer, PPQ, and launch activities.
• Assess site capabilities, Quality systems, and readiness; establish governance and escalation processes.
• Support health authority inspections and regulatory submissions; drive risk-based decision making.

Skills

Quality leadership

Regulatory compliance

GxP knowledge

Risk management

Process validation

Technical transfer

Data analytics

CAPA management

Cross-functional leadership

Change control

Education

Bachelor's degree in life sciences/biotech/engineering

Master's degree or equivalent

Job description

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

• 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

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

Pay Range: $184,600 - $277,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• educational assistance programs including student loan repayment
• a generous commuting subsidy
• matching charitable donations
• 401(k)
• and so much more

Flex Designation: Hybrid-Eligible Or On-Site Eligible

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.

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 [e-mail]

Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X

We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.