Senior Director, CGT Quality Systems & Personalized Medicine

Vertex Inc.; Boston (MA); Hybrid; USD 181,000 - 271,000; Full time

Job summary

Vertex Inc. is seeking a Senior Director of CGT Quality Systems to provide strategic quality leadership for personalized medicine and advanced cell therapies across the patient journey.

The role partners with Global Quality, Manufacturing, MS&T, Regulatory, Commercial, and Supply Chain to ensure patient-centric outcomes. The role requires building executive-level partnerships, strong communication, and the ability to balance long-term vision with flawless execution across CGT quality priorities.

Qualifications

• 15+ years of experience in regulated pharmaceutical environments.
• 7+ years in a management/supervisory role.
• Experience with allogeneic/autologous cell manufacturing or CGT modalities.
• In-depth knowledge of global health authority expectations and GxP.
• Ability to influence decisions with executive presence.

Responsibilities

• Provide strategic Quality leadership for CGT programs across patient journey.
• Define and execute CGT Quality Systems across lifecycle stages.
• Lead and mentor teams with accountability, collaboration, and operational excellence.
• Support risk-based mitigation and continuous improvement actions.
• Ensure compliance with global regulations and GMP requirements.

Skills

Quality Systems Leadership

CGT / Cell Therapy

Executive communication

Risk management

Cross-functional collaboration

Education

Bachelor’s degree in engineering or life sciences

Master’s degree preferred in analytics or life sciences

Job description

Vertex Inc. is seeking a Senior Director of CGT Quality Systems to provide strategic quality leadership for personalized medicine and advanced cell therapies across the patient journey.

The role partners with Global Quality, Manufacturing, MS&T, Regulatory, Commercial, and Supply Chain to ensure patient-centric outcomes. The role requires building executive-level partnerships, strong communication, and the ability to balance long-term vision with flawless execution across CGT quality priorities.