Director, CGT Quality & Process Excellence — Hybrid

Vertex Inc.; Boston (MA); Hybrid; USD 185,000 - 277,000; Full time

Job summary

Vertex Inc. seeks a Director, Manufacturing Process & Technical Quality to lead quality strategy and end-to-end oversight for CGT programs from development through commercialization and post-approval lifecycle.

You will collaborate across Development, Technical Operations, Manufacturing, Supply Chain, Regulatory, and external partners to ensure alignment with Vertex Quality Management System and global regulatory expectations while driving readiness and continuous improvement.

Qualifications

• Bachelor’s degree in life sciences, biotechnology, engineering, or a related discipline.
• Master’s degree or equivalent experience preferred.
• Typically 10+ years of progressive experience in Quality, manufacturing, technical operations, development, or Quality Control in biotech/pharma.
• At least 3 years of leadership experience with cross-functional teams.

Responsibilities

• Translate quality strategy into compliant execution plans and priorities.
• Provide end-to-end quality oversight from development through commercialization.
• Lead readiness for process scale-up, transfer, and launch.
• Identify and mitigate product, process, and regulatory risks.
• Coach and develop team members; manage budgets and resources.

Skills

Quality leadership

GxP knowledge

Regulatory affairs

Cross-functional collaboration

Strategic quality planning

Education

Bachelor’s degree in life sciences, biotechnology, engineering, or related discipline

Master’s degree or equivalent experience preferred

Job description

Vertex Inc. seeks a Director, Manufacturing Process & Technical Quality to lead quality strategy and end-to-end oversight for CGT programs from development through commercialization and post-approval lifecycle.

You will collaborate across Development, Technical Operations, Manufacturing, Supply Chain, Regulatory, and external partners to ensure alignment with Vertex Quality Management System and global regulatory expectations while driving readiness and continuous improvement.