Senior Clinical Study Quality Lead (Hybrid/On-Site)

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 138,000 - 207,000; Full time

Job summary

Vertex is seeking a Senior Manager, Clinical Study Quality Lead to provide study-level GCP quality oversight for assigned trials. You will partner with clinical study teams, CROs, vendors, and investigator sites to ensure compliance with ICH GCP E6(R3) and global regulations, and support inspection readiness.

The role requires a Bachelor’s degree and 6+ years of direct GCP QA experience in a sponsor or CRO setting.

Qualifications

• Bachelor’s degree and 6+ years of direct GCP QA experience.
• Hands-on GCP QA oversight for clinical trials in sponsor or CRO environments.
• Experience supporting clinical development programs for drugs/biologics.
• Strong knowledge of ICH GCP E6(R3) and global trial regulations.

Responsibilities

• Provide study-level GCP QA oversight for assigned trials.
• Partner with CROs, vendors, and sites to ensure inspection readiness.
• Conduct risk-based quality reviews of key study documents.
• Advise on risk-based mitigation strategies and CAPA planning.
• Develop investigator site audit plans and support audits/inspections.
• Monitor quality data and study-level trends; escalate risks as needed.

Skills

GCP QA oversight

Audit planning

CAPA planning

Risk-based quality

Inspection readiness

Cross-functional partnership

Quality data monitoring

Education

Bachelor’s degree

6+ years GCP QA experience

Job description

Vertex is seeking a Senior Manager, Clinical Study Quality Lead to provide study-level GCP quality oversight for assigned trials. You will partner with clinical study teams, CROs, vendors, and investigator sites to ensure compliance with ICH GCP E6(R3) and global regulations, and support inspection readiness.

The role requires a Bachelor’s degree and 6+ years of direct GCP QA experience in a sponsor or CRO setting.