Senior Manager, Clinical Study Quality Lead (Hybrid)
Vertex Pharmaceuticals
August 07, 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, applicable global regulations, study protocols, and Vertex procedures. Individual contributor role focused on GCP QA oversight (risk-based audits, 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; provide GCP QA oversight/guidance.
- Partner with clinical teams, CROs, vendors, and investigator sites; maintain inspection readiness.
- Conduct risk-based reviews of protocols, informed consent, and key study documents.
- Advise on quality risks and develop risk-based mitigation strategies.
- Develop/oversee investigator site audit plans; lead/support domestic/international audits.
- Review audit reports, responses, and CAPA plans; ensure timely resolution.
- Support quality issue investigations: root cause analysis, CAPA planning, effectiveness follow-up.
- Monitor quality data/trends and escalate significant risks.
- Support process improvement/continuous quality initiatives; contribute to SOP/work instruction review.
- Support regulatory agency inspections at Vertex and/or investigator sites.
Required Experience:
- Bachelor’s degree and 6+ years direct GCP QA oversight for clinical trials (hands-on required).
- Experience supporting clinical study quality in a sponsor/CRO or similarly regulated environment.
- Experience supporting clinical development programs for drugs/biologics.
Required Knowledge/Skills:
- Strong ICH GCP E6(R3) and global clinical regulations knowledge.
- Experience with audit support, inspection readiness, quality issue management, root cause analysis, CAPA.
- Risk-based quality principles; strong communication; independent, fast-paced, multi-priority execution.
Preferred Skills:
- Devices/combination products/cell & gene therapy trials.
- Phase 1 Clinical Research Unit GCP QA experience.
- Professional certification (e.g., RQAP-GCP, CCRP).
Other Requirements:
- Up to 10% travel.
Flex Designation:
- Hybrid: remote up to two days/week; or On-Site: five days/week on-site with ad hoc flexibility.
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, applicable global regulations, study protocols, and Vertex procedures. Individual contributor role focused on GCP QA oversight (risk-based audits, 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; provide GCP QA oversight/guidance.
- Partner with clinical teams, CROs, vendors, and investigator sites; maintain inspection readiness.
- Conduct risk-based reviews of protocols, informed consent, and key study documents.
- Advise on quality risks and develop risk-based mitigation strategies.
- Develop/oversee investigator site audit plans; lead/support domestic/international audits.
- Review audit reports, responses, and CAPA plans; ensure timely resolution.
- Support quality issue investigations: root cause analysis, CAPA planning, effectiveness follow-up.
- Monitor quality data/trends and escalate significant risks.
- Support process improvement/continuous quality initiatives; contribute to SOP/work instruction review.
- Support regulatory agency inspections at Vertex and/or investigator sites.
Required Experience:
- Bachelor’s degree and 6+ years direct GCP QA oversight for clinical trials (hands-on required).
- Experience supporting clinical study quality in a sponsor/CRO or similarly regulated environment.
- Experience supporting clinical development programs for drugs/biologics.
Required Knowledge/Skills:
- Strong ICH GCP E6(R3) and global clinical regulations knowledge.
- Experience with audit support, inspection readiness, quality issue management, root cause analysis, CAPA.
- Risk-based quality principles; strong communication; independent, fast-paced, multi-priority execution.
Preferred Skills:
- Devices/combination products/cell & gene therapy trials.
- Phase 1 Clinical Research Unit GCP QA experience.
- Professional certification (e.g., RQAP-GCP, CCRP).
Other Requirements:
- Up to 10% travel.
Flex Designation:
- Hybrid: remote up to two days/week; or On-Site: five days/week on-site with ad hoc flexibility.
Compensation:
- Pay range: $137,800–$206,800. Eligible for annual bonus and annual equity awards.