Associate Director, Quality Systems - Cell and Gene Therapies; VCGT

Position Summary

The Quality Systems Associate Director supports strategic design of and ensures tactical execution of quality systems, risk management, and quality culture across the Vertex Cell and Gene Therapy (VCGT) organization. The role partners with cross‑functional technical development and commercial teams to align and facilitate harmonization of strategy, procedures, and processes related to the Quality Management System, and to drive quality improvements.

• Process Lead for Annual Product Quality Review (APQR) and Quarterly Product Quality Assessment (QPQA)
  • Lead and provide functional process oversight for APQR and QPQA.
  • Ensure APQR and QPQA are executed on time and in accordance with procedures and regulatory requirements.
  • Monitor and support the quality risk management program items associated with CGT.
  • Identify and implement continuous improvement projects to improve processes and make them efficient and scalable.
• Process Lead for VCGT Data Integrity (DI) program
  • Define DI compliance operational strategies to be deployed at the local site level and monitored for effectiveness, including governance.
  • Collaborate with Global Process owner to identify and implement DI continuous improvement projects, mature processes, and make them efficient and scalable.
  • Responsible for local Quality system oversight, metrics, and improvement including change control, events, CAPA, escalation, and risk management.
  • Leads the monitoring, interpretation, and communication of QMS processes and metrics requirements, including remediation plans.
• Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions.
• Provide hands‑on expertise in the day‑to‑day management of data collection systems and control within the GxP Quality Management System using digital solutions.
• Responsible for strategic risk‑management monitoring support and data‑integrity initiatives to drive prioritization and continuous improvement across VCGT QMS/Compliance processes.
• Support internal audit or external audit programs.
• Work to enhance Quality Culture across the VCGT organization.
• Provide Project Management leadership for department projects and initiatives.

Bachelor’s degree in a scientific discipline, operations research, operations management, business administration or a related field.

10+ years of experience, or equivalent combination of education and experience. Experience in product life cycle from discovery to commercial product development.

• Broad and deep expertise in global GMP regulations, guidances, and Quality Management Systems, and strong understanding of industry standards and best practices across the GxP lifecycle.
• Strong leadership skills with ability to be agile and effectively collaborate in a dynamic, cross‑functional matrix environment.
• Ability to assess impact across multiple procedures and systems.
• Ability to lead and manage complex projects/teams within corporate objectives and project timelines.
• Proficiency utilizing project management processes/tools to lead meetings, assist with project planning, and facilitate completion of tasks.
• Excellent technical writing, presentation, and communication skills.
• Ability to effectively influence others within the technical area of expertise.
• Outstanding facilitation, communication, and coaching/influencing skills.
• Proven ability to lead improvement projects and project teams.
• Ability to navigate through ambiguity and rapid growth and adapt to change.
• Extensive experience conducting investigations, performing root cause analysis and identifying CAPA.

• Up to 15% travel.

$148,000 - $222,000. The range is a reasonable estimate for the base salary at the time of posting. This role is eligible for an annual bonus and annual equity awards.

Hybrid‑Eligible. The role can be designated as:
1) Hybrid– work remotely up to two days per week; or
2) On‑Site– work five days per week on‑site with ad hoc flexibility. Flex status is subject to Vertex’s policy and may change.

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 should make a request to the recruiter or hiring manager, or contact Talent Acquisition at A