Associate Director, Clinical Study Quality Lead (Hybrid)
Vertex Pharmaceuticals
August 07, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary: Clinical Study Quality Lead (SQL), Associate Director provides advanced quality assurance oversight of clinical trial operations and applicable vendors across study phases within assigned disease areas, ensuring GCP compliance and quality standards.
Key Duties and Responsibilities:
- Serve as GCP subject matter expert and technical resource for clinical study execution.
- Provide risk-based GCP quality compliance oversight to protect participant safety/rights/well-being and study data integrity.
- Consult on regulations/standards/quality systems; partner with study teams on proactive quality management.
- Identify and mitigate study/program quality risks; assess GCP compliance risks and implement quality risk management plans.
- Develop and execute risk-based quality/audit plans; review audit reports and responses/CAPAs.
- Lead inspection preparedness strategy; participate in inspections (prep through response).
- Conduct audits and inspection prep visits; oversee investigations; approve quality event investigations and CAPA(s).
- Represent Quality in governance/forums; contribute to procedural documents (CAPA, quality issue management, inspections, quality risk management).
- Evaluate/select GCP service providers; monitor quality indicators/metrics; optimize SOPs/work instructions.
- May act on behalf of the Clinical Quality Program Lead; mentor/train junior SQLs.
- Role may progress to people management responsibilities.
Education/Experience:
- Bachelor’s in scientific/allied health (or equivalent) and 8+ years relevant experience.
Required Experience/Skills:
- In-depth knowledge of ICH-GCP and global regulations (e.g., FDA, EMA, MHRA).
- Experience across clinical trial phases (drugs/biologics).
- Event management expertise (investigation, root cause, CAPA development, effectiveness checks).
- Strong communication, organizational, problem-solving, and conflict resolution skills; ability to prioritize and meet timelines.
- Scientific/medical terminology knowledge; independent and collaborative work.
- Proficient with Microsoft Office (Word, Excel, PowerPoint, Smartsheet, Visio).
- Experience with KPIs, metrics analysis, and quality/compliance trending.
Preferred/Other Requirements:
- Advantage: medical device manufacture-to-clinical transition or Cell & Gene Therapy.
- Preferred: professional certification (e.g., CCRP, RQAP-GCP).
- Travel up to 10%.
Pay Range: $160,600–$240,800.
Application Instructions:
- For accommodation requests: ApplicationAssistance@vrtx.com (if needed during hiring process/essential functions).
Key Duties and Responsibilities:
- Serve as GCP subject matter expert and technical resource for clinical study execution.
- Provide risk-based GCP quality compliance oversight to protect participant safety/rights/well-being and study data integrity.
- Consult on regulations/standards/quality systems; partner with study teams on proactive quality management.
- Identify and mitigate study/program quality risks; assess GCP compliance risks and implement quality risk management plans.
- Develop and execute risk-based quality/audit plans; review audit reports and responses/CAPAs.
- Lead inspection preparedness strategy; participate in inspections (prep through response).
- Conduct audits and inspection prep visits; oversee investigations; approve quality event investigations and CAPA(s).
- Represent Quality in governance/forums; contribute to procedural documents (CAPA, quality issue management, inspections, quality risk management).
- Evaluate/select GCP service providers; monitor quality indicators/metrics; optimize SOPs/work instructions.
- May act on behalf of the Clinical Quality Program Lead; mentor/train junior SQLs.
- Role may progress to people management responsibilities.
Education/Experience:
- Bachelor’s in scientific/allied health (or equivalent) and 8+ years relevant experience.
Required Experience/Skills:
- In-depth knowledge of ICH-GCP and global regulations (e.g., FDA, EMA, MHRA).
- Experience across clinical trial phases (drugs/biologics).
- Event management expertise (investigation, root cause, CAPA development, effectiveness checks).
- Strong communication, organizational, problem-solving, and conflict resolution skills; ability to prioritize and meet timelines.
- Scientific/medical terminology knowledge; independent and collaborative work.
- Proficient with Microsoft Office (Word, Excel, PowerPoint, Smartsheet, Visio).
- Experience with KPIs, metrics analysis, and quality/compliance trending.
Preferred/Other Requirements:
- Advantage: medical device manufacture-to-clinical transition or Cell & Gene Therapy.
- Preferred: professional certification (e.g., CCRP, RQAP-GCP).
- Travel up to 10%.
Pay Range: $160,600–$240,800.
Application Instructions:
- For accommodation requests: ApplicationAssistance@vrtx.com (if needed during hiring process/essential functions).