Senior Risk Management Lead: RBQM & Global Quality

AbbVie; California (MO); Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

Long-term incentive programs

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Risk Management Lead to drive Risk-Based Quality Management (RBQM) across global clinical trials. You will embed the RBQM model in study teams, collaborate with cross-functional leads to shape risk strategies, and lead RAMP meetings to ensure proactive risk mitigation and regulatory compliance.

The role requires a Bachelor’s degree in life sciences and at least 10 years in clinical operations with RBQM/quality management expertise, plus strong analytical and communication

Qualifications

• Bachelor’s degree in life sciences or related discipline; advanced degree preferred.
• Minimum of 10 years’ experience in clinical operations with RBQM or quality management.
• Excellent knowledge of risk management methodologies (identification, assessment, mitigation, documentation).
• Ability to influence cross-functional teams and senior management and drive change.
• Deep understanding of ICH/GCP, regulatory standards, and clinical trial processes.
• Strong analytical, critical thinking, and problem-solving skills; proficient with data analysis/visualization tools.
• Exceptional communication, documentation, and interpersonal skills.
• Proven ability to lead in a dynamic global environment with multi-jurisdictional studies.

Responsibilities

• Lead embedding and adoption of the end-to-end RBQM model within and across clinical study teams.
• Partner with cross-functional leads to develop and implement risk management strategies across therapeutic areas/programs.
• Facilitate RAMP meetings; prepare, review, and update RAMP documentation throughout the study lifecycle.
• Guide cross-functional teams in identifying critical data/processes, defining KRIs, and establishing risk controls and response plans.
• Ensure alignment of risk discussions with study plans and global monitoring strategies.
• Coach teams in risk mindset, methodology, and process maturity while fostering organizational capabilities.
• Analyze quality metrics/data and risk signals to drive continuous improvement.
• Monitor risk mitigation execution, track issues, and communicate risks/issues.
• Support inspection readiness, audit response, and regulatory compliance.
• Lead and contribute to RBQM process optimization and knowledge sharing.

Skills

RBQM

Risk management

Quality management

RAMP process

KRIs

Cross-functional

Data analysis

Regulatory knowledge

Stakeholder influence

Communication

Education

Bachelor's degree in life sciences or related discipline

Advanced degree preferred

Tools

Data analysis tools

Job description

AbbVie is seeking a Risk Management Lead to drive Risk-Based Quality Management (RBQM) across global clinical trials. You will embed the RBQM model in study teams, collaborate with cross-functional leads to shape risk strategies, and lead RAMP meetings to ensure proactive risk mitigation and regulatory compliance.

The role requires a Bachelor’s degree in life sciences and at least 10 years in clinical operations with RBQM/quality management expertise, plus strong analytical and communication