Associate Director QA, GMP External Ops (Hybrid)

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

Benefits offered by this job

Hybrid work option

Job summary

Vertex Pharmaceuticals LLC seeks an Associate Director of Quality Assurance for GMP External Operations. This role provides end-to-end QA oversight of external manufacturing CDMOs from development through commercial production, ensuring GMP compliance and robust risk management.

The position collaborates with internal and external stakeholders to enable successful technology transfer, scale-up, and reliable product supply, with travel up to 40% as needed.

Qualifications

• Bachelor's degree or equivalent; MS preferred.
• 8+ years in QA within a regulated pharmaceutical environment; 5+ years in a management/supervisory role.
• Knowledge of GMP requirements for Cell & Gene Therapy and Biologics (EU/FDA).
• Experience with external manufacturing oversight across development, tech transfer, launch and commercial manufacturing.

Responsibilities

• Lead QA strategy across development, tech transfer, launch, and commercial manufacturing.
• Provide end-to-end QA oversight for external manufacturing and CI/CDMO operations.
• Maintain QMS compliance, deviations, CAPAs, change controls, and audit readiness.
• Oversee Quality governance of CDMO manufacturing and readiness during tech transfer and ramp-up.

Skills

GMP knowledge

QA operations

External manufacturing

Cell therapy

Aseptic processing

Analytical testing

Fill/finish

Regulatory knowledge

Data analytics

Leadership

Risk management

Education

Bachelor's degree

Master's degree

Job description

Vertex Pharmaceuticals LLC seeks an Associate Director of Quality Assurance for GMP External Operations. This role provides end-to-end QA oversight of external manufacturing CDMOs from development through commercial production, ensuring GMP compliance and robust risk management.

The position collaborates with internal and external stakeholders to enable successful technology transfer, scale-up, and reliable product supply, with travel up to 40% as needed.