Quality and Risk Lead

Job Description Quality and Risk Lead Location: Denver, CO Industry: Clinical Research / Healthcare / Oncology Salary: Based on experience Employment Type: Direct hire We are seeking an experienced Executive Director to lead Quality Management, Training, and Site Regulatory Affairs across a multi-site clinical research organization. This role provides strategic leadership, ensures regulatory and quality compliance, and drives consistent, inspection-ready processes across all sites. Job Overview: The Executive Director will oversee Quality, Training, and Site Regulatory teams while developing companywide strategies, processes, and standards. This position reports to the VP of Quality and serves as a senior escalation point for quality, compliance, training, and regulatory matters. Primary Responsibilities: Lead Quality Management, Training, and Site Regulatory departments. Oversee the companywide QMS, SOPs, CAPAs, audits, inspections, and regulatory compliance. Develop and maintain clinical research training programs and curricula. Oversee site regulatory activities from study start-up through close-out. Manage Regional Regulatory Managers and ensure consistent regulatory processes across sites. Maintain inspection readiness and support sponsor audits and regulatory inspections. Monitor regulatory requirements, including FDA guidance, ICH GCP, and IRB requirements. Establish KPIs and reporting for quality, training, and regulatory performance. Partner with senior leadership, sponsors, CROs, IRBs, and site leadership. Lead, mentor, and develop department leaders and staff. Support staffing, budgeting, vendor management, and process improvement initiatives. Qualifications: Bachelor s degree required; Master s preferred. 5+ years of oncology experience Experience leading regulatory operations across multiple sites or regions. Experience managing regulatory managers/supervisors. Experience with study start-up, regulatory cycle times, sponsor audits, and regulatory inspections. Experience developing and managing clinical research training programs. Strong knowledge of GCP, FDA regulations, ICH E6/E6(R3), IRB requirements, QMS, SOPs, and CAPA. Excellent leadership, communication, presentation, problem-solving, and negotiation skills. Proficiency with Microsoft Office 365 and e-learning tools.

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EOE/ADA The Staffing Resource Group Inc