Associate Director QA, GMP External Operations

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

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.

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

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.

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, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status

In this Hybrid-Eligible role, you can choose to be designated as:

• Hybrid: work remotely up to two days per week; or select
• On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [e-mail]