Associate Director, Manufacturing Process and Technical Quality Assurance Cell and Genetic Therapies - VCGT
Vertex Pharmaceuticals
August 06, 2026
Remote friendly (Boston, MA)
United States
Operations
General Summary:
- Provide end-to-end quality oversight for cell and gene therapy programs across clinical development, commercialization, launch, and post-approval lifecycle management. Establish product quality standards, align with regulatory expectations/industry best practices, and proactively identify/mitigate product quality risks.
Key Duties And Responsibilities:
- Serve as Quality Assurance SME for product/process lifecycle management (GxP, Vertex QMS, personalized medicine requirements).
- Lead QA review/approval of stage-gate deliverables, process development, technology transfers, process validations, and new product introductions.
- Develop/maintain quality and compliance frameworks aligned with evolving CGT expectations.
- Support continuous improvement from development through commercialization; review process specs/reports/validation/regulatory submissions (including Health Authority inquiry responses).
- Represent Quality on CMC Governance forums to ensure compliant strategies, transfers, and manufacturing changes.
- Lead/support quality review of investigations, deviations, change controls, risk assessments, and compliance issues.
- Support inspection readiness and Health Authority interactions; support development of quality systems/processes and continuous improvement.
- Provide Quality oversight for internal manufacturing and external CMOs.
- Apply digital/AI tools and analytics (e.g., MES, eQMS, data visualization) to enhance quality oversight, risk management, monitoring, and decision-making.
Knowledge & Skills / Qualifications:
- In-depth global regulatory and technical knowledge across GxP QA/QC in cell therapies.
- Preferred: MES, LIMS, eQMS, data visualization, advanced analytics.
- Ability to lead improvement projects (e.g., Root Cause Analysis, operational excellence).
- Enterprise influence; critical thinking and problem solving.
Education & Experience:
- Bachelor’s degree (scientific/allied health or equivalent).
- Preferred: additional Master’s (business/scientific).
- 8+ years in regulated pharmaceutical environment (or equivalent).
Pay Range:
- $156,600 - $234,800.
Flex Designation:
- Hybrid (remote up to 2 days/week) or On-Site (5 days/week on-site with ad hoc flexibility).
- Provide end-to-end quality oversight for cell and gene therapy programs across clinical development, commercialization, launch, and post-approval lifecycle management. Establish product quality standards, align with regulatory expectations/industry best practices, and proactively identify/mitigate product quality risks.
Key Duties And Responsibilities:
- Serve as Quality Assurance SME for product/process lifecycle management (GxP, Vertex QMS, personalized medicine requirements).
- Lead QA review/approval of stage-gate deliverables, process development, technology transfers, process validations, and new product introductions.
- Develop/maintain quality and compliance frameworks aligned with evolving CGT expectations.
- Support continuous improvement from development through commercialization; review process specs/reports/validation/regulatory submissions (including Health Authority inquiry responses).
- Represent Quality on CMC Governance forums to ensure compliant strategies, transfers, and manufacturing changes.
- Lead/support quality review of investigations, deviations, change controls, risk assessments, and compliance issues.
- Support inspection readiness and Health Authority interactions; support development of quality systems/processes and continuous improvement.
- Provide Quality oversight for internal manufacturing and external CMOs.
- Apply digital/AI tools and analytics (e.g., MES, eQMS, data visualization) to enhance quality oversight, risk management, monitoring, and decision-making.
Knowledge & Skills / Qualifications:
- In-depth global regulatory and technical knowledge across GxP QA/QC in cell therapies.
- Preferred: MES, LIMS, eQMS, data visualization, advanced analytics.
- Ability to lead improvement projects (e.g., Root Cause Analysis, operational excellence).
- Enterprise influence; critical thinking and problem solving.
Education & Experience:
- Bachelor’s degree (scientific/allied health or equivalent).
- Preferred: additional Master’s (business/scientific).
- 8+ years in regulated pharmaceutical environment (or equivalent).
Pay Range:
- $156,600 - $234,800.
Flex Designation:
- Hybrid (remote up to 2 days/week) or On-Site (5 days/week on-site with ad hoc flexibility).