Senior GCP QA Lead – Clinical Study Quality (Hybrid)

Regulatory Jobs; Boston (MA); Hybrid; USD 138,000 - 207,000; Full time

Benefits offered by this job

Hybrid-Eligible

Job summary

Vertex is seeking a Senior Manager, Clinical Study Quality Lead to oversee GCP QA for assigned trials, collaborating with study teams, CROs, vendors and sites to ensure compliance with ICH GCP and global regulations. This on-site or hybrid role supports inspection readiness and quality improvements across Vertex clinical programs.

The ideal candidate has 6+ years of hands-on GCP QA experience in sponsor/CRO settings and a strong background in drugs/biologics development, with a Bachelor’s

Qualifications

• Bachelor’s degree required with 6+ years of direct GCP QA experience.
• Hands-on GCP QA oversight for clinical trials in sponsor/CRO settings.
• Experience supporting clinical development programs for drugs/biologics.

Responsibilities

• Provide study-level GCP QA oversight for assigned trials and guide study teams.
• Partner with CROs, vendors and sites to support quality oversight and inspection readiness.
• Conduct risk-based quality reviews of protocols and key documents to identify compliance risks.
• Advise on quality risks and develop practical mitigation strategies.
• Develop and oversee site audit plans and ensure alignment with study risk and company expectations.
• Lead or support domestic and international investigator site audits and inspections.
• Review audit reports and CAPA plans to ensure timely resolution of findings.
• Support quality issue investigations including root cause analysis and CAPA follow-up.
• Monitor quality data and study trends, escalate significant risks as needed.
• Contribute to process improvements and GCP compliance initiatives.

Skills

GCP QA oversight

Audit planning

Quality risk assessment

Communication

Project management

Inspection readiness

Education

Bachelor’s degree

Job description

Vertex is seeking a Senior Manager, Clinical Study Quality Lead to oversee GCP QA for assigned trials, collaborating with study teams, CROs, vendors and sites to ensure compliance with ICH GCP and global regulations. This on-site or hybrid role supports inspection readiness and quality improvements across Vertex clinical programs.

The ideal candidate has 6+ years of hands-on GCP QA experience in sponsor/CRO settings and a strong background in drugs/biologics development, with a Bachelor’s