Senior RBQM Risk Leader for Global Clinical Trials

AbbVie; Irvine (CA); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Health insurance

401(k)

Job summary

AbbVie is seeking a Risk Management Lead in Irvine, CA to drive RBQM adoption across global trials. You will partner with study teams to build proactive risk-management culture and ensure regulatory compliance throughout the study lifecycle.

With 10+ years in clinical operations and strong analytical skills, you will define KRIs, lead RAMP, and mentor cross-functional teams. This hybrid role requires onsite presence 3 days weekly and collaboration across regions.

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• 10+ years in clinical operations with risk management expertise.
• Deep knowledge of ICH/GCP and regulatory standards; strong analytical skills.

Responsibilities

• Lead embedding of end-to-end RBQM model across study teams.
• Develop and implement risk management strategies across programs.
• Facilitate RAMP meetings and maintain RBQM documentation.
• Define KRIs and establish risk controls and response plans.
• Align risk discussions with study plans and monitoring strategies.
• Coach teams on risk mindset and process maturity.
• Analyze quality metrics and risk signals to drive improvement.
• Monitor mitigation execution and document risks and actions.
• Support inspection readiness and regulatory compliance.
• Contribute to RBQM process optimization and knowledge sharing.

Skills

RBQM expertise

Risk management

Data analysis

Cross-functional leadership

ICH/GCP knowledge

Communication skills

Education

Bachelor's degree in life sciences or related

Job description

AbbVie is seeking a Risk Management Lead in Irvine, CA to drive RBQM adoption across global trials. You will partner with study teams to build proactive risk-management culture and ensure regulatory compliance throughout the study lifecycle.

With 10+ years in clinical operations and strong analytical skills, you will define KRIs, lead RAMP, and mentor cross-functional teams. This hybrid role requires onsite presence 3 days weekly and collaboration across regions.