Director, Global Clinical Quality - Quality Oversight Lead (Remote Eligible)

Director, Global Clinical Quality - Quality Oversight Lead (Remote Eligible)

The Director, Quality Oversight Lead within Global Clinical Quality (GCQ) is responsible for strategic and operational oversight of key activities such as inspection readiness, the GCQ operational framework, continuous improvement initiatives, and expert guidance on computer systems assurance in a clinical trial setting. Additionally, the Director will provide quality oversight to Clinical Development and Biometrics functional areas.

Job Description

We seek an individual with strong leadership skills, expert drug development and GCP knowledge, and advanced understanding of the application of inspection readiness principles in a clinical trial setting.

This position reports directly to the Senior Director of Global Clinical Quality and will be a key member of the GCQ Leadership Team.

Key Duties & Responsibilities

• Partner with cross‑functional teams to identify and implement measurable and sustainable enhancements in the clinical trial space.
• Lead a team that implements an effective inspection strategy alongside cross‑functional clinical study teams for Vertex submissions globally.
• Lead a team that provides quality support on computer systems assurance as it relates to GCP and clinical trials.
• Lead a team that provides quality support to Clinical Development and Biometrics functional areas.
• Implement and manage the GCQ operational framework, including GCQ internal operations, metrics and dashboards, and internal governance.
• Promote a culture of continuous improvement and accountability.
• Manage people including resource forecasting, hiring, employee goal setting, performance management, and career development; may also manage contract staff.
• Engage and consult business partners to advance proactive quality approaches incorporating best practices and developing strategies for new models, technologies, and practices across clinical development.

Required Education Level

• B.S. in a scientific or allied health field preferred; mix of relevant experience and B.S. in other field will be considered.

Required Experience

• Typically 10+ years of relevant work experience, including a GCP quality role or comparable background.
• Line management or supervisory experience required.

Required Knowledge/Skills

• Excellent understanding of ICH‑GCP guidelines and international clinical trial regulations.
• Leadership in inspection readiness strategy and planning for FDA, MHRA, NMPA and other agencies.
• Experience applying risk‑based quality principles (e.g., QbD) in a pharmaceutical environment.
• Experience providing quality support to Clinical Development and Biometrics functional areas.
• Deep understanding of computer systems assurance for clinical trials and related guidelines.
• Strong leadership capabilities and team development within a multi‑level organization.
• Current knowledge of industry trends and best practices for progressive quality risk management.
• Strong problem‑solving, critical thinking and analytical/Data‑analysis skills.

Other

• Professional clinical trial certification (e.g., CCRP, RQAP‑GCP, etc.).
• Continuous Improvement and Project Management training or certifications.
• Travel up to 25% to Vertex sites, vendors, investigator sites, etc.

Pay Range

$174,400 – $261,600 per annum.

Disclosure Statement

The range provided is a reasonable estimate for the base salary at the time of posting. This role may be eligible for an annual bonus, annual equity awards, overtime pay (as required by law), and other compensation based on skills, experience and job factors.

Vertex offers inclusive market‑leading benefits, including medical, dental, vision, paid time off, educational assistance, commuting subsidy, charitable matching, 401(k) and more.

Flex Designation

Remote‑Eligible

Flex Eligibility Status

• Remote: work remotely five days per week and visit office on occasions.
• Hybrid: work remotely up to two days per week.
• On‑Site: work five days per week on‑site with ad hoc flexibility.

Flex status is subject to Vertex’s Policy on Flex @ Vertex Program and may change at any time.

Company Information

Vertex is a global biotechnology company investing in scientific innovation.

Equal Employment Opportunity

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. Applicants requiring an accommodation should contact the recruiter or hiring manager, or Talent Acquisition at

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