Senior Manager, Clinical Study Quality Lead (GCP)

Location: Boston, MA, United States. Hybrid work is available remotely up to two days per week, or the role may be performed on-site five days per week. Up to 10% travel may be required.

Salary: $137,800–$206,800 per year, plus eligibility for an annual bonus and annual equity awards.

Company

Vertex is a global biotechnology company focused on scientific innovation and the development of medicines.

What you will do

• Provide study-level GCP quality assurance oversight for assigned clinical trials.
• Partner with clinical study teams, CROs, vendors, and investigator sites to maintain quality and inspection readiness.
• Conduct risk-based reviews of protocols, informed consent documents, and other study documentation.
• Develop and oversee investigator site audit plans and lead or support domestic and international site audits.
• Review audit reports, responses, and CAPA plans, and support investigations, root cause analysis, and effectiveness follow-up.
• Monitor clinical quality data and compliance trends, escalate significant risks, and support regulatory inspections and process improvement.

Requirements

• Bachelor’s degree and 6+ years of direct GCP Quality Assurance experience overseeing clinical trials, or an equivalent combination of education and experience.
• Hands-on clinical trial GCP QA experience in a sponsor, CRO, or similarly regulated clinical research environment.
• Experience supporting clinical development programs for drugs and biologics.
• Strong knowledge of ICH GCP E6(R3), global clinical trial regulations, audit support, inspection readiness, quality issue management, root cause analysis, and CAPA.
• Ability to assess GCP compliance risks, apply risk-based quality principles, manage priorities independently, and collaborate with internal and external stakeholders.

Nice to have

• Experience with devices, combination products, or cell and gene therapy clinical trials.
• Experience supporting GCP QA activities in a Phase 1 Clinical Research Unit.
• Professional certification such as RQAP-GCP or CCRP.

Culture & Benefits

• Hybrid or on-site work arrangements under the Flex @ Vertex program.
• Medical, dental, and vision benefits with paid time off and company shutdowns in summer and winter.
• Educational assistance, student loan repayment support, commuting subsidy, charitable donation matching, and 401(k).
• Support for continuous learning and adoption of advances in AI, technology, and automation.