Senior QA Leader, External GMP Operations

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 157,000 - 235,000; Full time

Job summary

Vertex Pharmaceuticals is seeking an Associate Director, Quality Assurance GMP Operations in Boston to provide end-to-end QA oversight of external manufacturing across CDMOs, from development through commercial production. You will ensure GMP compliance, drive risk management, and partner with internal and external teams to sustain product quality and supply.

You will lead QA strategy, establish governance, and oversee deviations, investigations, CAPAs, and change controls while guiding

Qualifications

• In-depth knowledge of global GMP regulatory requirements for Cell & Gene Therapy and/or Biologics.
• Strong knowledge of QA operations across development, tech transfer, launch, and commercial manufacturing.
• QA experience in autologous cell therapy preferred.

Responsibilities

• Provide end-to-end QA oversight from development through ramp-up to routine manufacturing execution.
• Establish the QA oversight model, governance, escalation pathways and performance expectations.
• Oversee deviations, investigations, CAPAs, change controls and quality risk assessments.

Skills

GMP knowledge

QA leadership

Regulatory knowledge

Risk management

Data analytics

Communication

Education

Bachelor's degree in life sciences

Master's degree preferred

Job description

Vertex Pharmaceuticals is seeking an Associate Director, Quality Assurance GMP Operations in Boston to provide end-to-end QA oversight of external manufacturing across CDMOs, from development through commercial production. You will ensure GMP compliance, drive risk management, and partner with internal and external teams to sustain product quality and supply.

You will lead QA strategy, establish governance, and oversee deviations, investigations, CAPAs, and change controls while guiding