Head of QA, GMP External Operations

MFS Investments; Boston (MA); Hybrid; USD 157,000 - 235,000; Full time

Job summary

Vertex Pharmaceuticals in Boston, MA seeks an Associate Director of Quality Assurance for GMP External Operations to oversee external manufacturing partners from tech transfer through commercial production. You will lead QA oversight, risk management, and compliance programs to ensure product quality and regulatory readiness.

The role requires deep GMP knowledge for biologics/cell therapies, strong cross-functional leadership, and the ability to drive quality improvements across CDMOs while

Qualifications

• 8+ years of experience in a regulated pharmaceutical environment.
• 5+ years in a management/supervisory role.
• Knowledge of global GMP/regulatory requirements for Cell & Gene Therapy and/or Biologics (EU GMP, FDA).
• Strong QA operations knowledge across development, tech transfer, launch, and commercial manufacturing.
• Experience with autologous cell therapy preferred.
• Excellent communication and stakeholder management.

Responsibilities

• Provide end-to-end QA oversight across CDMOs from process development through commercial manufacturing.
• Lead QA governance, escalation, and performance expectations; identify/mitigate risks.
• Oversee deviations, investigations, CAPAs, change controls, and quality risk assessments.
• Monitor audit/regulatory readiness and ensure GMP compliance.
• Collaborate cross-functionally to enable compliant and reliable execution.

Education

Bachelor's degree

Master's degree

Tools

GMP

Job description

Vertex Pharmaceuticals in Boston, MA seeks an Associate Director of Quality Assurance for GMP External Operations to oversee external manufacturing partners from tech transfer through commercial production. You will lead QA oversight, risk management, and compliance programs to ensure product quality and regulatory readiness.

The role requires deep GMP knowledge for biologics/cell therapies, strong cross-functional leadership, and the ability to drive quality improvements across CDMOs while