External QA Lead, GMP Operations (Hybrid)

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

Benefits offered by this job

Annual bonus

Equity awards

401(k)

Job summary

Vertex Pharmaceuticals is seeking an Associate Director, Quality Assurance GMP Operations to provide end-to-end QA oversight of external manufacturing across CDMOs, from development through commercial execution. You will partner with internal and external teams to ensure compliant, reliable operations and a robust Quality Culture.

The role leads the QA oversight model, manages deviations and CAPAs, drives digitization, and ensures GMP compliance across quantity processes.

Qualifications

• In-depth knowledge of global GMP requirements for Cell & Gene Therapy/Biologics, incl. EU GMPs and FDA.
• Strong QA operations knowledge across development, transfer, launch, and commercial manufacturing.
• QA operational experience in cell therapy preferred.

Responsibilities

• Provide end-to-end QA oversight from development through ramp-up and routine manufacturing.
• Ensure GMP compliance for manufacturing and product disposition activities.
• Lead deviations, investigations, CAPAs, change controls, and risk assessments.
• Build effective cross-functional partnerships to ensure compliant execution.

Skills

QA leadership

GMP knowledge

Regulatory knowledge

Quality risk management

Data analytics

Cross-functional collaboration

Education

Bachelor's degree

Master's degree preferred

Tools

CAPA tracking systems

Regulatory documentation tools

Job description

Vertex Pharmaceuticals is seeking an Associate Director, Quality Assurance GMP Operations to provide end-to-end QA oversight of external manufacturing across CDMOs, from development through commercial execution. You will partner with internal and external teams to ensure compliant, reliable operations and a robust Quality Culture.

The role leads the QA oversight model, manages deviations and CAPAs, drives digitization, and ensures GMP compliance across quantity processes.