Global Risk Management Lead, RBQM & Quality Excellence

AbbVie; Florham Park (NJ); Hybride; USD 150 000 - 190 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

401(k) plan

Paid time off

Résumé du poste

AbbVie in Lake County, IL; Florham Park, NJ, Irvine, CA, or other locations. The Risk Management Lead (RML) drives risk-based quality management across global clinical trials, partnering with study teams to embed RBQM and foster a proactive risk-mitigation culture for high-quality study execution.

The role requires a senior level of expertise in risk management, RBQM, and regulatory standards, with strong data analysis and cross-functional collaboration skills.

Qualifications

• Bachelor’s degree in life sciences or related discipline; advanced degree preferred.
• Minimum of 10 years’ experience in clinical operations with risk management, RBQM or quality management.
• Excellent knowledge of risk management methodologies (identification, assessment, mitigation, documentation).
• Ability to influence cross-functional teams and drive change in a global, multi-jurisdictional setting.
• Strong understanding of ICH/GCP, regulatory standards, and clinical trial processes.
• Proficient in data analysis/visualization tools and clear communication.

Responsabilités

• Lead embedding and adoption of the RBQM model across clinical study teams.
• Partner with cross-functional leads to implement risk management strategies.
• Facilitate RAMP meetings and maintain RAMP documentation throughout the lifecycle.
• Identify critical data/processes, define KRIs, and establish risk controls and response plans.
• Ensure alignment of risk discussions with study plans and global monitoring strategies.
• Coach teams on risk mindset, methodology, and process maturity; promote best practices.
• Analyze quality metrics and risk signals to drive continuous improvement and early intervention.
• Monitor risk mitigation execution, track trends, and document risks and issues.
• Support inspection readiness, audits, and regulatory compliance with QA partners.
• Lead RBQM process optimization and knowledge sharing across studies.

Connaissances

Risk management

RBQM

Regulatory knowledge

Data analysis

Stakeholder influence

Communication

Formation

Bachelor’s degree in life sciences or related discipline

Advanced degree preferred

Outils

Data analysis tools

Visualization tools

Description du poste

AbbVie in Lake County, IL; Florham Park, NJ, Irvine, CA, or other locations. The Risk Management Lead (RML) drives risk-based quality management across global clinical trials, partnering with study teams to embed RBQM and foster a proactive risk-mitigation culture for high-quality study execution.

The role requires a senior level of expertise in risk management, RBQM, and regulatory standards, with strong data analysis and cross-functional collaboration skills.