Quality And Risk Lead

Quality and Risk LeadLocation: Denver, COIndustry: Clinical Research / Healthcare / OncologySalary: Based on experienceSchedule: Monday FridayEmployment Type: Direct hireWe are seeking an experienced Quality and Risk Lead 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 Quality and Risk Lead 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 study teams in risk management assessment, planning, and mitigation. Drive risk management activities and tracking, ensuring risk oversight and activities are updated as appropriate based on study progress, changes, and risks.
• Support study teams in identification, investigation, and remediation of quality issues, including root cause, corrective and preventive action, and effectiveness check discussions.
• Provide oversight, transparency, and tracking of quality issues for assigned studies and when required, provide metrics to leadership.
• Actively participate in key internal project team meetings and facilitate quality discussions.
• Provide expert quality advice to study teams and site leadership, responding to consultancy requests for best practices, process optimization, and regulatory requirements.
• Partner with study teams and site leadership to achieve and maintain a state of inspection readiness. Communicate with Quality Management leadership regarding readiness, risks, and gaps.
• Identify areas for continuous improvement of the Quality Management System by sharing feedback on processes and participating in process improvement initiatives as requested.
• Communicate regularly within QM team to share lessons learned.
• Support study teams and site leadership with study-specific training requirements and compliance oversight.

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.

IND123EOE/ADA