Associate Director QA, GMP External Operations

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:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 
1.    Hybrid: work remotely up to two days per week; or select
2.    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. 

#LI-Hybrid
 

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 [email protected]