Clinical Study Quality Lead - Hybrid/On-Site QA (GCP)

Vertex Pharmaceuticals Incorporated; Boston (MA); Híbrido; USD 124.000 - 207.000; Jornada completa

Descripción de la vacante

Vertex Pharmaceuticals Incorporated seeks a Senior Manager, Clinical Study Quality Lead to provide study-level GCP QA oversight for assigned trials and partner with clinical study teams, CROs, and investigator sites. The role focuses on risk-based audit strategy, CAPA support, and inspection readiness in a sponsor-regulated environment.

Required are aBachelor's degree and 6+ years of hands-on GCP QA experience, with strong knowledge of ICH GCP E6(R3) and global regulations.

Formación

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

Responsabilidades

• Serve as the Clinical Study Quality Lead for assigned trials, providing GCP QA oversight and guidance.
• Partner cross-functionally with clinical study teams, CROs, vendors, and investigator sites to support quality oversight.
• Conduct risk-based quality reviews of protocols, informed consent documents, and other key study documentation.
• Advise study teams on quality risks and mitigation strategies.
• Develop and oversee investigator site audit plans aligned with study risk and expectations.
• Lead and/or support domestic and international investigator site audits and inspections readiness.
• Review audit reports, responses, and CAPA plans to ensure timely resolution.
• Support quality issue investigations, including root cause analysis and CAPA follow-up.
• Review and monitor clinical quality data, compliance signals, and study-level trends.

Conocimientos

GCP QA

ICH GCP E6(R3)

Quality oversight

Audit planning

CAPA management

Regulatory compliance

Stakeholder collaboration

Inspection readiness

Root cause analysis

Risk-based thinking

Educación

Bachelor's degree

6+ years GCP QA experience

Descripción del empleo

Vertex Pharmaceuticals Incorporated seeks a Senior Manager, Clinical Study Quality Lead to provide study-level GCP QA oversight for assigned trials and partner with clinical study teams, CROs, and investigator sites. The role focuses on risk-based audit strategy, CAPA support, and inspection readiness in a sponsor-regulated environment.

Required are aBachelor's degree and 6+ years of hands-on GCP QA experience, with strong knowledge of ICH GCP E6(R3) and global regulations.