QA Executive — External GMP Operations Leader

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

Job summary

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

The role ensures compliant operations, robust risk management, and strong partnerships to support product quality and supply, collaborating with internal technical, manufacturing, regulatory, and

Qualifications

• 8+ years of experience in a regulated pharmaceutical environment.
• 5+ years in a management/supervisory role or equivalent.

Responsibilities

• Provide Quality leadership and strategic direction across development, tech transfer, launch, and commercial manufacturing.
• Establish QA oversight model, governance, escalation pathways, and performance expectations.
• Identify and mitigate key Quality and operational risks.
• Advance digitization and tech-enabled QA solutions.
• Provide end-to-end QA oversight from process development through ramp-up and routine manufacturing execution.
• Ensure regulatory and GMP compliance of manufacturing and product disposition activities.
• Lead for operational issues impacting manufacturing, product quality, or supply.
• Partner cross-functionally to enable compliant and reliable execution.
• Oversee deviations, investigations, CAPAs, change controls, and risk assessments.
• Maintain audit and regulatory inspection readiness.
• Monitor CDMO Quality performance and timely escalation/resolution of significant issues.

Skills

GMP Regulations

QA Operations

Technology Transfer

Risk Management

Data Analytics

Strategic Planning

Root Cause Analysis

Decision Making

Communication Skills

Stakeholder Management

Education

Bachelor's degree

Master's degree preferred

Job description

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

The role ensures compliant operations, robust risk management, and strong partnerships to support product quality and supply, collaborating with internal technical, manufacturing, regulatory, and