Senior Manager, Clinical Study Quality Lead (Hybrid)

Key Duties And Responsibilities

• Serve as the Clinical Study Quality Lead for assigned trials, providing GCP QA oversight and guidance to clinical study teams and key stakeholders.
• Partner cross-functionally with clinical study teams, CROs, vendors, and investigator sites to support quality oversight and maintain inspection readiness.
• Conduct risk-based quality reviews of protocols, informed consent documents, and other key study documentation to identify potential compliance and operational risks.
• Advise clinical study teams on quality risks and support the development of practical, risk-based mitigation strategies.
• Develop and oversee investigator site audit plans for assigned studies, ensuring alignment with study risk, audit strategy, and company expectations.
• Lead and/or support domestic and international investigator site audits and inspection readiness activities.
• Review audit reports, responses, and CAPA plans to ensure findings are appropriately assessed, addressed, and resolved in a timely manner.
• Support quality issue investigations, including root cause analysis, CAPA planning, and follow-up of effectiveness measures.
• Review and monitor clinical quality data, compliance signals, and study-level trends, escalating significant risks or concerns as appropriate.
• Contribute to ongoing process improvement and continuous quality initiatives to strengthen GCP compliance across clinical programs.
• Support regulatory agency inspections at Vertex and/or clinical investigator sites, as needed.
• May contribute to the review of SOPs, work instructions, and internal guidance documents that support the clinical quality management system.

Required Experience

• Bachelor’s degree and 6+ years of direct GCP Quality Assurance experience providing oversight for clinical trials, or the equivalent combination of education and experience.
• Candidates must have direct, hands-on experience providing GCP QA oversight for clinical trials.
• Experience supporting clinical study quality in a sponsor, CRO, or similarly regulated clinical research environment.
• Experience supporting clinical development programs for drugs and biologics.

Required Knowledge/Skills

• Strong knowledge of ICH GCP E6(R3) and applicable global clinical trial regulations and guidance.
• Demonstrated experience in GCP clinical trial quality oversight, including audit support, inspection readiness, quality issue management, root cause analysis, and CAPA.
• Ability to identify GCP compliance risks, assess impact, and apply risk-based quality principles in a clinical trial environment.
• Strong communication skills, with the ability to work effectively across internal and external stakeholders.
• Ability to work independently, manage multiple priorities, and deliver high-quality work in a fast-paced environment.
• Strong organizational, project management, and problem-solving skills.