Associate Director of Risk Management

Job Summary

Reporting remotely, the full-time Associate Director of Risk Management will develop and implement Risk Based Quality Management (RBQM) procedures, coordinate risk identification and monitoring activities, and support quality control efforts across studies within the pharmaceutical industry.

Key responsibilities

• Develops RBQM processes at program, portfolio, and asset levels to manage risks effectively
• Contributes to the creation of a lessons learned framework to enhance future studies based on RBQM insights
• Acts as a change agent and subject matter expert in RBQM methodology, leading study teams in best practices

Required qualifications

• 8+ years of experience in the pharmaceutical or CRO industry
• 3+ years of experience in Risk Based Quality Management
• 2+ years of managerial and supervisory experience
• Robust understanding of the drug development process and clinical trial execution
• Knowledge of industry regulatory standards including 21 CFR Part 11 and ICH guidelines