Clinical Study Quality Lead — Senior Manager, GCP Oversight

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 138,000 - 207,000; Full time

Benefits offered by this job

Hybrid work option

Competitive total rewards

Job summary

Vertex Pharmaceuticals is seeking a Senior Manager, Clinical Study Quality Lead to provide study-level quality oversight for assigned clinical trials, ensuring GCP compliance with global regulations, study protocols, and Vertex procedures.

The role partners with clinical study teams, CROs, vendors, and investigator sites to support quality outcomes across Vertex programs, including risk-based audit strategy, CAPA support, and inspection readiness. On-site or hybrid work is available.

Qualifications

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

Responsibilities

• Provide study-level GCP QA oversight and guidance to clinical study teams and stakeholders.
• Lead risk-based quality reviews of protocols and essential documents to identify compliance risks.
• Develop and oversee investigator site audit plans and support domestic/international audits and inspections.

Skills

GCP QA

Risk-based QA

CAPA management

Root cause analysis

Audit support

Regulatory knowledge

Cross-functional

Project management

Communication skills

Education

Bachelor's degree

Job description

Vertex Pharmaceuticals is seeking a Senior Manager, Clinical Study Quality Lead to provide study-level quality oversight for assigned clinical trials, ensuring GCP compliance with global regulations, study protocols, and Vertex procedures.

The role partners with clinical study teams, CROs, vendors, and investigator sites to support quality outcomes across Vertex programs, including risk-based audit strategy, CAPA support, and inspection readiness. On-site or hybrid work is available.