Director, CGT Process & Quality Excellence (Hybrid)

Vertex Pharmaceuticals LLC; Boston, Northern (MA, KY); Hybrid; USD 185,000 - 277,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Comprehensive benefits

Job summary

Vertex Pharmaceuticals LLC seeks a Director, Manufacturing Process & Technical Quality for Boston. You will provide end‑to‑end Quality oversight for CGT programs from development through commercialization and post‑approval lifecycle management.

You will drive quality strategy, risk mitigation, and readiness across development, manufacturing, and supply chain, influencing stakeholders and ensuring compliance with GxP and Vertex QMS.

Qualifications

• Bachelor’s degree in life sciences, biotechnology, engineering or a related discipline.
• Master’s degree or equivalent is preferred.

Responsibilities

• Lead Quality oversight from development through commercialization and post‑approval lifecycle management.
• Define phase-appropriate product, process, analytical, and control strategy expectations.
• Support health authority inspections and regulatory interactions.

Skills

GxP knowledge

Regulatory submissions

AAV/Cell technology

Process development

Quality leadership

Root Cause Analysis

Data analytics

LEAN / Six Sigma

Cross-functional leadership

Problem solving

Education

Bachelor's degree in life sciences/biotech/engineering

Master's degree or equivalent

Tools

Regulatory systems

Quality management systems

Job description

Vertex Pharmaceuticals LLC seeks a Director, Manufacturing Process & Technical Quality for Boston. You will provide end‑to‑end Quality oversight for CGT programs from development through commercialization and post‑approval lifecycle management.

You will drive quality strategy, risk mitigation, and readiness across development, manufacturing, and supply chain, influencing stakeholders and ensuring compliance with GxP and Vertex QMS.