Associate Director, Clinical Study Quality Lead (Hybrid)
Vertex Pharmaceuticals
August 29, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Clinical Study Quality Lead (SQL), Associate Director
Responsibilities
- Serve as GCP subject matter expert and key technical resource for clinical study execution.
- Provide risk-based GCP quality compliance oversight to ensure protection of participant safety/rights/well-being and integrity of study data.
- Interpret and advise on regulations, standards, and quality systems.
- Partner with clinical/study teams for proactive quality management and timely risk communication/mitigation.
- Participate in risk management forums; develop and implement quality risk management plans.
- Develop and execute risk-based quality and/or audit plans; review audit reports and CAPA responses.
- Lead inspection preparedness strategy and support inspections (prep through response); conduct directed/for-cause audits and site prep visits.
- Oversee quality event investigations and approve CAPA(s).
- Provide status updates to Quality Leadership/senior stakeholders; provide direction at management reviews.
- Represent Quality in governance/forums and interdepartmental process improvement initiatives.
- Contribute to Quality Management System procedural documents (e.g., CAPA, Quality Issue Management, inspections, quality risk management).
- Participate in evaluation/selection of GCP service providers; monitor quality indicators/metrics to optimize SOPs/work instructions.
- Mentor/train junior SQLs; may assume people management responsibilities (hiring, execution oversight, goal setting, performance management, career development).
Education/Experience
- Bachelor’s degree in scientific/allied health field (or equivalent) and 8+ years relevant experience.
Required/Preferred Skills
- In-depth knowledge of ICH-GCP and applicable global regulations (FDA/EMA/MHRA, etc.).
- Experience across clinical trial phases for drugs and biologics.
- Strong event management knowledge (investigations, root cause analysis, CAPA plans, effectiveness checks).
- Ability to translate business needs into creative, risk-based quality approaches.
- Clear written/verbal communication; strong organizational, problem-solving, and conflict resolution skills.
- Ability to prioritize/work independently and collaboratively; proficient with MS Word/Excel/PowerPoint, Smartsheet, Visio.
- Experience using KPIs and trending/monitoring quality/compliance metrics.
Other requirements
- Medical device manufacturing/transition to clinical studies or Cell & Gene Therapy experience is advantageous.
- Professional GCP certification (e.g., CCRP, RQAP-GCP) preferred.
- Travel up to 10% to Vertex sites/vendors/investigator sites.
Responsibilities
- Serve as GCP subject matter expert and key technical resource for clinical study execution.
- Provide risk-based GCP quality compliance oversight to ensure protection of participant safety/rights/well-being and integrity of study data.
- Interpret and advise on regulations, standards, and quality systems.
- Partner with clinical/study teams for proactive quality management and timely risk communication/mitigation.
- Participate in risk management forums; develop and implement quality risk management plans.
- Develop and execute risk-based quality and/or audit plans; review audit reports and CAPA responses.
- Lead inspection preparedness strategy and support inspections (prep through response); conduct directed/for-cause audits and site prep visits.
- Oversee quality event investigations and approve CAPA(s).
- Provide status updates to Quality Leadership/senior stakeholders; provide direction at management reviews.
- Represent Quality in governance/forums and interdepartmental process improvement initiatives.
- Contribute to Quality Management System procedural documents (e.g., CAPA, Quality Issue Management, inspections, quality risk management).
- Participate in evaluation/selection of GCP service providers; monitor quality indicators/metrics to optimize SOPs/work instructions.
- Mentor/train junior SQLs; may assume people management responsibilities (hiring, execution oversight, goal setting, performance management, career development).
Education/Experience
- Bachelor’s degree in scientific/allied health field (or equivalent) and 8+ years relevant experience.
Required/Preferred Skills
- In-depth knowledge of ICH-GCP and applicable global regulations (FDA/EMA/MHRA, etc.).
- Experience across clinical trial phases for drugs and biologics.
- Strong event management knowledge (investigations, root cause analysis, CAPA plans, effectiveness checks).
- Ability to translate business needs into creative, risk-based quality approaches.
- Clear written/verbal communication; strong organizational, problem-solving, and conflict resolution skills.
- Ability to prioritize/work independently and collaboratively; proficient with MS Word/Excel/PowerPoint, Smartsheet, Visio.
- Experience using KPIs and trending/monitoring quality/compliance metrics.
Other requirements
- Medical device manufacturing/transition to clinical studies or Cell & Gene Therapy experience is advantageous.
- Professional GCP certification (e.g., CCRP, RQAP-GCP) preferred.
- Travel up to 10% to Vertex sites/vendors/investigator sites.