Associate Director, GMP Quality CGT & Personalized Medicine

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 148,000 - 222,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Comprehensive benefits

Hybrid work options

Job summary

Vertex is seeking an Associate Director, GMP Quality for CGT Personalized Medicine to lead and evolve quality systems, risk management, and quality culture across the Vertex Cell and Gene Therapy organization.

The role partners with cross‑functional development and commercial teams to harmonize strategy, procedures and processes for CGT, drive improvements, data integrity, change management, and lifecycle governance.

Qualifications

• Broad and deep expertise in global GMP regulations, guidances, and Quality Management.
• Strong leadership skills with agility in cross-functional matrix environment.
• Ability to lead and manage complex projects/teams within objectives and timelines.
• Proficiency in project management processes/tools for meetings, planning, tasks.
• Excellent technical writing, presentation and communication skills.
• Ability to influence others within technical area; navigate ambiguity and rapid growth.

Responsibilities

• Oversee Quality Systems for Personalized Medicine within CGT from design through sustainment.
• Establish compliance governance to monitor trends, performance, and risks.
• Collaborate with internal/external partners to resolve complex quality issues.
• Lead monitoring, interpretation of QMS processes and remediation plans.
• Process lead for VCGT Change Management and lifecycle management.
• Drive CGT process execution and problem-solving with cross-functional stakeholders.
• Enable delivery of strategic change plans with QA and cross-functional teams.
• Execute end-to-end process improvement across clinical, launch and commercial lifecycles.
• Provide feedback to enhance VCGT processes and system improvements.
• Define and deploy Data Integrity compliance strategy at the local site level.
• Apply standards to data/investigations into Data Integrity failures.
• Oversee CGT Quality Systems to improve compliance and performance.
• Enhance Quality Culture and lead continuous improvement initiatives.

Skills

GMP Regulations

Quality Management

Cross-functional Leadership

Project Management

Technical Writing

Influence & Coaching

Data Integrity

Quality Improvement

Risk Management

Education

Bachelor's degree in science

Tools

Quality Management Systems (QMS)

Job description

Vertex is seeking an Associate Director, GMP Quality for CGT Personalized Medicine to lead and evolve quality systems, risk management, and quality culture across the Vertex Cell and Gene Therapy organization.

The role partners with cross‑functional development and commercial teams to harmonize strategy, procedures and processes for CGT, drive improvements, data integrity, change management, and lifecycle governance.