Risk Management Jobs 2026 (Now Hiring) – Smart Auto Apply

Quality and Risk LeadLocation: Denver, COIndustry: Clinical Research / Healthcare / OncologySalary: Based on experienceSchedule: Monday FridayEmployment Type: Direct hireWe 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.

Why Join Us:

• Direct hire opportunity with long-term career growth potential.
• Comprehensive medical, dental, and vision insurance.
• 401(k) with a 100% employer match on the first 4% of employee contributions.
• Tuition reimbursement.
• Paid parental leave.
• Employee referral bonus program.
• Employee Assistance Program (EAP).
• Life and disability insurance.
• Generous paid time off including 15 days of PTO, 8 paid holidays, and 2 floating holidays.
• Collaborative, mission-driven culture with opportunities for professional development and advancement.
• Opportunity to make a meaningful impact by supporting employees who help advance innovative healthcare and clinical research initiatives.

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