Clinical Study Quality Lead, Associate Director

General

Summary:

The 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. Ensures trials are conducted per GCP requirements, protocols, Vertex policies/procedures, and Quality Management System standards. Leads audit/quality plans, communicates compliance risks, oversees action plans, and drives inspection readiness.

• Serve as a GCP technical resource; assure quality risk management/mitigation and compliance to protect subject safety, rights, well-being, and data integrity.
• Liaise with clinical functions and external parties (CROs, vendors, investigators) to promote consistent quality.
• Partner with QA and business leadership for quality/compliance of internal operations and vendors.
• Participate on Integrated Risk Governance Team; develop/implement risk mitigation; lead Stage Gate Reviews.
• Provide guidance on regulations/standards/quality systems; develop and measure quality metrics.
• Develop and lead inspection readiness and conduct directed/for-cause audits and site prep visits.
• Oversee quality event investigations and approve investigations/CAPA(s).
• Develop risk-based audit plans; ensure audits, review reports, evaluate responses and CAPA; elevate significant risks.
• Oversee investigation and quality compliance forums; mentor junior SQLs as needed.

• In-depth ICH-GCP knowledge and global regulations guidance (e.g., FDA/EMA/MHRA).
• Experience across drug and biologics clinical trial phases.
• Event management expertise (investigations, root cause analysis, CAPA plans, effectiveness checks).
• Ability to translate business needs into risk-based quality approaches.
• Strong communication, organization, problem-solving, and prioritization; independent and collaborative work.
• Proficiency in Microsoft Office (Word/Excel/PowerPoint), Smartsheet, Visio.
• Strong KPI/metrics analysis and quality/compliance trending.

Bachelor’s degree in a scientific or allied health field (or equivalent) and 8+ years relevant work experience.

• Prior experience with medical device manufacture/transition to clinical studies or Cell & Gene Therapy is advantageous.
• Professional clinical trial certification preferred (e.g., CCRP, RQAP-GCP).
• Travel up to 10%.

• Annual bonus and annual equity awards.