Clinical Study Quality Lead, Senior Manager (Hybrid)
About The Position
The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to help ensure they are conducted in compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols, and Vertex procedures. This is an individual contributor role focused on GCP quality assurance oversight for clinical trials, including risk-based audit strategy, quality risk identification, issue escalation, CAPA support, compliance trend analysis, and inspection readiness. The role partners closely with clinical study teams and external stakeholders, including CROs, vendors, and investigator sites, to support quality outcomes across Vertex clinical programs. The ideal candidate brings direct, hands-on GCP QA experience supporting clinical trials in a sponsor, CRO, or similarly regulated clinical research environment.
Requirements
- 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.
- 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.
Nice To Haves
- Experience supporting devices, combination products, or cell and gene therapy clinical trials.
- Experience supporting GCP QA activities in a Phase 1 Clinical Research Unit is highly desirable.
- Professional certification such as RQAP-GCP, CCRP, or similar.
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.
Benefits
- annual bonus
- annual equity awards
- overtime pay
- medical, dental and vision benefits
- generous paid time off (including a week-long company shutdown in the Summer and the Winter)
- educational assistance programs including student loan repayment
- generous commuting subsidy
- matching charitable donations
- 401(k)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
