Associate Director QA, GMP External Operations

Vertex Pharmaceuticals LLC; 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

Job Description

General/Position Summary: The Associate Director, Quality Assurance GMP Operations provides end-to-end QA oversight of external manufacturing operations across CDMOs, from process development and technology transfer through manufacturing readiness, ramp-up, and routine clinical and commercial execution. The role ensures compliant and reliable operations, effective Quality risk management, and strong internal and external partnerships to support product quality and supply.

The role partners closely with internal technical, manufacturing, supply chain, regulatory, and Quality functions, as well as external CDMO Quality and Operations teams, to establish robust and sustainable operations, enable successful transfer and scale-up, resolve operational Quality issues, and maintain a state of compliance throughout the product lifecycle. A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders for advancing quality outcomes and operational excellence.

Key Duties & Responsibilities

Leadership & Quality Strategy

• Provide Quality leadership and strategic direction across development, technology transfer, launch, and commercial manufacturing.
• Establish the QA oversight model, governance, escalation pathways, and performance expectations.
• Identify and mitigate key Quality and operational risks.
• Advance digitization and technology-enabled solutions to improve QA oversight, efficiency, and decision making.

QA Operational Oversight

• Provide end-to-end QA oversight from process development and technology transfer through baseline operations, ramp-up, and routine manufacturing execution.
• Ensure manufacturing and product disposition activities meet regulatory and GMP requirements.
• Provide Quality leadership for operational issues impacting manufacturing, product quality, or supply.
• Partner cross-functionally to enable compliant and reliable execution.

QMS & Compliance

• Ensure compliance with applicable GMP requirements, regulatory commitments, and the Quality Management System.
• Oversee deviations, investigations, CAPAs, change controls, and Quality risk assessments.
• Monitor Quality and compliance performance and emerging risks.
• Maintain audit and regulatory inspection readiness.

External Manufacturing Quality

• Provide independent Quality oversight and governance of CDMO manufacturing operations.
• Assess Quality readiness during technology transfer, start-up, ramp-up, and routine manufacturing.
• Monitor CDMO Quality performance and ensure timely escalation and resolution of significant issues.
• Build effective CDMO partnerships while maintaining clear Quality accountability.

Required Education Level

Batchelor's degree or relevant comparable background. Masters preferred.

Required Experience

8+ years of experience and 5+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment

Required Knowledge/Skills

• In-depth knowledge of global GMP regulatory requirements for Cell & Gene Therapy and/or Biologics, including EU GMPs and FDA requirements.
• Strong knowledge of QA operations and external manufacturing across development, technology transfer, launch, and commercial manufacturing.
• QA operational experience in autologous cell therapy preferred.
• Broad technical knowledge of cell therapy processing, aseptic manufacturing, analytical testing, and fill/finish.
• Demonstrated capability in strategic planning, risk management, root cause analysis, data analytics, and operational excellence.
• Strong critical thinking, problem-solving, and risk-based decision-making skills.
• Excellent communication and influencing skills with the ability to build effective internal and external partnerships and promote a strong Quality culture.

Other Requirements

Up to 40% Travel may be required

Pay Range

$156,600 - $234,800

Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family an