Associate Director, Manufacturing Process and Technical Quality Assurance Cell and Genetic Ther[...]

Job Description General Summary: The Manufacturing Process & Technical Quality Associate Director provides end-to-end quality oversight for cell and gene therapy programs across clinical development, commercialization, product launch, and post-approval lifecycle management. The role is responsible for establishing product quality standards for both established and emerging technologies, ensuring alignment with regulatory expectations and industry best practices, and proactively identifying and mitigating product quality risks throughout the product lifecycle and end to end patient journey. This position partners closely with Manufacturing, Technical Operations, Regulatory Affairs, and Quality stakeholders to support program execution and governance, ensuring business, regulatory, quality, and operational objectives are achieved while maintaining the highest standards of patient safety and product quality.

Key Duties and Responsibilities

Process Lifecycle Management

Serve as a Quality Assurance Subject Matter Expert (SME) for product and process lifecycle management, ensuring compliance with GxP regulations, and Vertex Quality Management System (QMS) including personalized medicine requirements. Lead QA review and approval of stage-gate deliverables, process development activities, technology transfers, process validations, and new product introductions across the product lifecycle. Drive the development, implementation, and maintenance of quality and compliance frameworks, standards, and strategies to ensure products and processes remain aligned with evolving regulatory and industry CGT expectations. Partner with Development, Technical Operations, Manufacturing, and Supply Chain functions to support continuous improvement initiatives throughout development to commercialization. Support preparation and review of process-related specifications, development reports, validation documentation, and regulatory submissions, including responses to Health Authority inquiries. Serve as the Quality representative on CMC Governance forums to ensure compliant lifecycle strategies, technical transfers, and manufacturing changes.

Compliance & Investigations

Lead and/or support quality review of complex investigations, deviations, change controls, risk assessments, and compliance issues impacting product quality or manufacturing processes. Partner with cross-functional teams to identify product, process and quality and compliance risks, assess impact, and implement appropriate mitigation strategies. Support inspection readiness activities and participate in Health Authority inspections, regulatory interactions, information requests, and corrective action commitments. Support development of Vertex quality systems and processes. Identify, facilitate, and/or lead continuous improvement efforts.

Technical Operations & CMO Management

Provide Quality oversight and strategic partnership for internal manufacturing operations and external contract manufacturing organizations (CMOs) supporting product lifecycle activities. Support implementation of standardized quality practices, lifecycle management strategies, and continuous improvement initiatives across internal and external manufacturing networks.

Digital & Artificial Intelligence

Demonstrate understanding of digital manufacturing, process lifecycle management platforms, data analytics, automation technologies, and emerging AI applications within regulated GxP environments. Utilize digital tools, advanced analytics, and AI-enabled solutions to enhance quality oversight, risk management, process monitoring, and operational decision-making. Leverage systems such as MES, eQMS, data visualization platforms, process monitoring tools, and advanced analytics to assess product quality performance throughout the lifecycle.

Knowledge and Skills

• In-depth global regulatory agency and technical knowledge and experience across GXP QA and QC activities in cell therapies.
• Experience with platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics is preferred.
• Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience.
• Enterprise Impact & Influence with the ability to shape decisions across the organization through strong partnerships, communication, and presence.
• Critical Thinking and Problem Solving skills

Education and Experience

• Bachelor’s degree in a scientific or allied health field (or equivalent degree).
• Preferred additional Master’s degree at Business /Scientific level.
• 8+ years of experience, or the equivalent combination of education and experience in a regulated pharmaceutical environment.

Pay Range

Pay Range: $156,600 - $234,800 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. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.

Benefits

• Medical, dental and vision benefits
• Generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• Educational assistance programs
• Student loan repayment
• A generous commuting subsidy
• Matching charitable donations
• 401(k)
• and so much more

Flex Designation

• Hybrid: work remotely up to two days per week.
• On-Site: work five days per week on-site with ad hoc flexibility.

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 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 View email address on click.appcast.io. Vertex is an E-Verify Employer in the United States. Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. 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 APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency. Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is 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 14 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 or follow us on Facebook, Twitter/X, LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.