Senior QA Leader, GMP External Manufacturing

Vertex Pharmaceuticals; Boston (MA); On-site; USD 157,000 - 235,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Total Rewards benefits

Job summary

Vertex Pharmaceuticals seeks an Associate Director of Quality Assurance GMP Operations to provide end-to-end QA oversight of external manufacturing across CDMOs, spanning process development, technology transfer, and routine clinical and commercial execution.

This role partners with internal technical, manufacturing, regulatory, and Quality teams, as well as external CDMO partners, to ensure compliant, reliable operations, effective risk management, and readiness throughout the product lifecycle.

Qualifications

• Bachelor's degree in a relevant field; advanced degree preferred.
• Minimum 8+ years in regulated pharma with 5+ years in a management role.
• Deep knowledge of global GMP requirements for Cell & Gene Therapy/Biologics, including FDA/EU.

Responsibilities

• Provide end-to-end QA oversight across CDMOs from development to commercial manufacturing.
• Lead QA governance, escalation, and performance expectations.
• Manage deviations, investigations, CAPAs, and change controls; monitor risk and compliance.

Skills

Quality leadership

GMP compliance

Risk management

Data analytics

Communication

Education

Bachelor's degree

Master's degree preferred

Tools

QMS experience

CAPA process

Job description

Vertex Pharmaceuticals seeks an Associate Director of Quality Assurance GMP Operations to provide end-to-end QA oversight of external manufacturing across CDMOs, spanning process development, technology transfer, and routine clinical and commercial execution.

This role partners with internal technical, manufacturing, regulatory, and Quality teams, as well as external CDMO partners, to ensure compliant, reliable operations, effective risk management, and readiness throughout the product lifecycle.