Associate Director QA, GMP External Oper

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... For full info follow application link.

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 Human Resources at ApplicationAssistance@vrtx.com.