Senior Manager, Clinical Study Quality Lead (Hybrid)
Vertex Pharmaceuticals
June 25, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to ensure compliance with GCP, global regulations, study protocols, and Vertex procedures. Individual contributor; supports GCP QA oversight (risk-based audit strategy, quality risk identification, issue escalation, CAPA support, compliance trend analysis, inspection readiness). On-site or hybrid; not fully remote.
Key Duties and Responsibilities:
- Serve as Clinical Study Quality Lead and provide GCP QA oversight/guidance.
- Partner with clinical study teams, CROs, vendors, and investigator sites; maintain inspection readiness.
- Perform risk-based reviews of protocols, informed consent documents, and key study documents.
- Advise on quality risks and support risk-based mitigation strategies.
- Develop/oversee investigator site audit plans; lead/support domestic and international site audits.
- Review audit reports, responses, and CAPA plans for timely resolution.
- Support quality issue investigations (root cause analysis, CAPA planning, effectiveness follow-up).
- Monitor quality data and trends; escalate significant risks/concerns.
- Support regulatory inspections and may contribute to SOP/work instruction review.
Required Experience:
- Bachelor’s degree and 6+ years direct GCP Quality Assurance oversight for clinical trials (or equivalent).
- Hands-on GCP QA oversight experience in a sponsor/CRO or similarly regulated environment.
- Experience supporting clinical study quality and drug/biologics development programs.
Required Knowledge/Skills:
- Strong ICH GCP E6(R3) and global clinical regulations knowledge.
- Experience with audit/inspection readiness, quality issue management, root cause analysis, CAPA.
- Risk-based quality principles, strong communication, independent execution, organization/project management.
Preferred Skills:
- Devices/combination products or cell & gene therapy trial experience.
- GCP QA experience in a Phase 1 Clinical Research Unit.
- Professional certification (e.g., RQAP-GCP, CCRP).
Other Requirements:
- Up to 10% travel.
- Hybrid/on-site flex designation allowed.
Compensation:
- Pay range: $137,800–$206,800; eligible for annual bonus and annual equity awards.
Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to ensure compliance with GCP, global regulations, study protocols, and Vertex procedures. Individual contributor; supports GCP QA oversight (risk-based audit strategy, quality risk identification, issue escalation, CAPA support, compliance trend analysis, inspection readiness). On-site or hybrid; not fully remote.
Key Duties and Responsibilities:
- Serve as Clinical Study Quality Lead and provide GCP QA oversight/guidance.
- Partner with clinical study teams, CROs, vendors, and investigator sites; maintain inspection readiness.
- Perform risk-based reviews of protocols, informed consent documents, and key study documents.
- Advise on quality risks and support risk-based mitigation strategies.
- Develop/oversee investigator site audit plans; lead/support domestic and international site audits.
- Review audit reports, responses, and CAPA plans for timely resolution.
- Support quality issue investigations (root cause analysis, CAPA planning, effectiveness follow-up).
- Monitor quality data and trends; escalate significant risks/concerns.
- Support regulatory inspections and may contribute to SOP/work instruction review.
Required Experience:
- Bachelor’s degree and 6+ years direct GCP Quality Assurance oversight for clinical trials (or equivalent).
- Hands-on GCP QA oversight experience in a sponsor/CRO or similarly regulated environment.
- Experience supporting clinical study quality and drug/biologics development programs.
Required Knowledge/Skills:
- Strong ICH GCP E6(R3) and global clinical regulations knowledge.
- Experience with audit/inspection readiness, quality issue management, root cause analysis, CAPA.
- Risk-based quality principles, strong communication, independent execution, organization/project management.
Preferred Skills:
- Devices/combination products or cell & gene therapy trial experience.
- GCP QA experience in a Phase 1 Clinical Research Unit.
- Professional certification (e.g., RQAP-GCP, CCRP).
Other Requirements:
- Up to 10% travel.
- Hybrid/on-site flex designation allowed.
Compensation:
- Pay range: $137,800–$206,800; eligible for annual bonus and annual equity awards.