Senior Manager, Clinical Study Quality Lead
Vertex Pharmaceuticals
August 06, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to ensure compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols, and Vertex procedures. On-site or hybrid (not fully remote).
Key Duties and Responsibilities:
- Serve as Clinical Study Quality Lead for assigned trials; provide GCP QA oversight and guidance.
- Partner with clinical study teams, CROs, vendors, and investigator sites to support quality oversight and inspection readiness.
- Perform risk-based quality reviews of protocols, informed consent documents, and key study documentation.
- Advise teams on quality risks and support practical, risk-based mitigation strategies.
- Develop/oversee investigator site audit plans; lead/support domestic and international site audits.
- Review audit reports, responses, and CAPA plans; ensure timely assessment, resolution, and follow-up.
- Support quality issue investigations (root cause analysis, CAPA planning, effectiveness follow-up).
- Monitor quality data/compliance signals and escalate significant risks.
- Contribute to process improvement and continuous quality initiatives.
- Support regulatory inspections as needed.
- May contribute to review of SOPs/work instructions.
Required Experience:
- Bachelor’s degree and 6+ years of hands-on GCP Quality Assurance oversight for clinical trials.
- Experience supporting clinical study quality (sponsor/CRO or similarly regulated environment).
- Experience in clinical development programs for drugs and biologics.
Required Knowledge/Skills:
- ICH GCP E6(R3) and global clinical trial regulations.
- Audit support, inspection readiness, quality issue management, root cause analysis, CAPA.
- Risk-based quality principles; strong communication; independent, multi-priority execution; strong organization/project management.
Preferred Skills:
- Devices/combination products or cell and gene therapy experience.
- GCP QA experience in a Phase 1 Clinical Research Unit.
- Certifications such as RQAP-GCP or CCRP.
Other Requirements:
- Up to 10% travel may be required.
The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to ensure compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols, and Vertex procedures. On-site or hybrid (not fully remote).
Key Duties and Responsibilities:
- Serve as Clinical Study Quality Lead for assigned trials; provide GCP QA oversight and guidance.
- Partner with clinical study teams, CROs, vendors, and investigator sites to support quality oversight and inspection readiness.
- Perform risk-based quality reviews of protocols, informed consent documents, and key study documentation.
- Advise teams on quality risks and support practical, risk-based mitigation strategies.
- Develop/oversee investigator site audit plans; lead/support domestic and international site audits.
- Review audit reports, responses, and CAPA plans; ensure timely assessment, resolution, and follow-up.
- Support quality issue investigations (root cause analysis, CAPA planning, effectiveness follow-up).
- Monitor quality data/compliance signals and escalate significant risks.
- Contribute to process improvement and continuous quality initiatives.
- Support regulatory inspections as needed.
- May contribute to review of SOPs/work instructions.
Required Experience:
- Bachelor’s degree and 6+ years of hands-on GCP Quality Assurance oversight for clinical trials.
- Experience supporting clinical study quality (sponsor/CRO or similarly regulated environment).
- Experience in clinical development programs for drugs and biologics.
Required Knowledge/Skills:
- ICH GCP E6(R3) and global clinical trial regulations.
- Audit support, inspection readiness, quality issue management, root cause analysis, CAPA.
- Risk-based quality principles; strong communication; independent, multi-priority execution; strong organization/project management.
Preferred Skills:
- Devices/combination products or cell and gene therapy experience.
- GCP QA experience in a Phase 1 Clinical Research Unit.
- Certifications such as RQAP-GCP or CCRP.
Other Requirements:
- Up to 10% travel may be required.