Senior RBQM Risk Leader - Quality & Compliance

SmartRecruiters, Inc.; North Chicago (IL); Hybrid; USD 125,000 - 237,000; Full time

Job summary

AbbVie is seeking a Risk Management Lead to oversee risk-based quality management across global clinical trials. You will lead strategic planning, implement risk mitigation, and partner with study teams to foster proactive risk cultures.

The role requires 10+ years in clinical operations, strong RBQM expertise, and ability to influence cross-functional teams. This hybrid role is onsite Tue-Thu, with local candidates in Lake County, IL; Irvine, CA; or Florham Park, NJ.

Qualifications

• Bachelor’s degree in life sciences or related discipline; advanced degree preferred.
• 10+ years in clinical operations with risk management or RBQM experience.
• Strong knowledge of risk management methodologies and documentation.
• Ability to influence cross-functional teams and drive change.
• Deep understanding of ICH/GCP and regulatory standards.
• Excellent analytical, communication, and problem-solving skills.

Responsibilities

• Lead end-to-end RBQM adoption within study teams.
• Develop and implement risk management strategies across programs.
• Facilitate RAMP meetings and maintain RBQM documentation.
• Define KRIs and risk controls with cross-functional teams.
• Ensure alignment with study plans and monitoring strategies.
• Coach teams in risk mindset and process maturity.
• Analyze quality metrics and risk signals for continuous improvement.
• Support inspection readiness and regulatory compliance.
• Lead RBQM process optimization and knowledge sharing.

Skills

Risk management

RBQM expertise

Regulatory compliance

Data analysis

Cross-functional influence

Communication

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

Data visualization tools

Statistical software

Job description

AbbVie is seeking a Risk Management Lead to oversee risk-based quality management across global clinical trials. You will lead strategic planning, implement risk mitigation, and partner with study teams to foster proactive risk cultures.

The role requires 10+ years in clinical operations, strong RBQM expertise, and ability to influence cross-functional teams. This hybrid role is onsite Tue-Thu, with local candidates in Lake County, IL; Irvine, CA; or Florham Park, NJ.