Quality and Risk Lead

Staffing Resource Group, Inc; Lakewood (CO); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) match

Tuition reimbursement

Parental leave

Referral program

Employee Assistance Program

Life and disability insurance

Paid time off

Job summary

Staffing Resource Group, Inc. is seeking an experienced Quality and Risk Lead to oversee Quality Management, Training, and Site Regulatory Affairs across a multi-site clinical research organization.

You will provide strategic leadership, ensure regulatory compliance, drive inspection-ready processes, and partner with study teams to enhance quality across all sites.

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.

Responsibilities

• Lead study teams in risk management assessment, planning, and mitigation.
• Drive risk management activities and tracking, ensuring risk oversight and updates.
• Support study teams in identification, investigation, and remediation of quality issues.
• Provide oversight, transparency, and metrics to leadership.
• Facilitate quality discussions in internal project team meetings.
• Provide expert quality advice to study teams and site leadership.
• Partner with teams to achieve inspection readiness.
• Communicate readiness, risks, and gaps to QM leadership.
• Identify areas for continuous improvement of the Quality Management System.
• Share lessons learned within QM team.
• Support training requirements and compliance oversight.

Skills

Leadership

Communication

Problem solving

Negotiation

GCP knowledge

Education

Bachelor's degree

Master's degree preferred

Tools

Microsoft Office 365

e-learning tools

Regulatory management software

Job description

Location: Denver, CO

Industry: Clinical Research / Healthcare / Oncology

Salary: Based on experience

Schedule: Monday Friday

Employment Type: Direct hire

Job Overview

We 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.

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.

IND123 EOE/ADA