Job Description General Summary:
The Manufacturing Process & Technical Quality Associate Director provides end-to-end l 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
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.
#LI-Hybrid
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
$156,600 - $234,800
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.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.