Director QA, GMP External Operations Cell and Genetic Therapies - VCGT

Overview

Job Description for the Director, Quality Assurance GMP Operations. The role provides end-to-end quality oversight for Cell & Gene CDMOs, supporting quality assurance activities across development, launch, and commercial manufacturing globally. The role partners with operational stakeholders to lead quality and technical risk mitigation, drive governance, and support on-site manufacturing activities at the CDMO as needed.

Key Duties & Responsibilities

• Establish quality oversight for external CTO/CDMO operations, including on-time batch disposition across development, launch, and commercial manufacturing globally.
• Lead, develop, and implement continuous quality improvements to advance quality outcomes and operational excellence in processes.
• Proactively develop compliance metrics as key indicators and take action to mitigate.
• Maintain full oversight of the CDMO Quality Management System (QMS), drive deviation reduction, and assure timely resolution of CAPAs.
• Act as the SME for the CDMO, understanding the scope of all changes and driving applicable global change control with external manufacturing partners to meet global product goals.
• Represent Quality and act as a trusted partner for the disposition activities of drug products.
• Build strategic relationships and foster a culture of collaboration with internal and external partners (CDMOs and CTOs) to ensure Quality issues are raised and addressed as needed.
• Lead and support the development of quality and technical risk mitigation by identifying and mitigating compliance gaps.
• Lead and mentor other team members, supporting development of organizational capabilities and talent.
• Serve as the batch disposition subject matter expert (SME) in support of regulatory inspections and audits.
• Establish, participate in, and lead GxP Cell & Gene Therapy Management Reviews to gain insights on efficiency and operational performance, and identify opportunities for improvement and actions.
• Work with cross-functional partners to prepare for and support Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate corrective actions.
• Represent C&G Quality in complex projects and collaborate with key stakeholders for alignment on strategic and operational planning and delivery of business and financial priorities.
• May be required to support on-site manufacturing activities.

Required Education

• Bachelor's degree or relevant comparable background.
• Master's degree preferred.

Required Experience

10+ 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 global health regulatory agency knowledge and experience across the GXP life cycle in Cell & Gene therapy and/or Biologics (EU GMPs, FDA 21CFR Part 1271, GxPs).
• Broad and current knowledge of batch disposition industry trends and best practices in Cell/Gene therapies.
• Preferred QA Operational experience for Autologous Cell Therapy Operations.
• Broad technical knowledge in cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/ biologics processing, fill/finish, and testing.
• Demonstrated strategic planning and execution skills for operational effectiveness and compliance, with proficiency in root cause analysis, data analytics, and Operational Excellence (e.g., LEAN, DMAIC, Six Sigma).
• Excellent communication skills and a proven track record of influencing and promoting a culture of Quality and Excellence.
• Ability to apply risk management principles to decision making and operational priorities.
• Critical thinking and problem-solving skills.
• Ability to closely collaborate and build relationships with internal and external stakeholders.

Other Requirements

Indicate required certifications, licenses, or specialized trainings. Up to 25% travel may be required.

Flex Designation

Hybrid-Eligible or On-Site Eligible

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 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 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 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