Senior Manager – RBQM Operations

• Implement and coordinate RBQM procedures at the study level
• Review study protocols and facilitate development of Study Risk Assessments defining critical data, critical processes, and key risk indicators
• Develop study-specific content and lead RBQM training and kick-off meetings
• Author and implement study-specific RBQM plans
• Lead risk assessment meetings with cross-functional study team members throughout the trial lifecycle
• Partner with the RBQM system configuration team to ensure risk indicators, quality tolerance limits, and analytics/visualizations function as required
• Perform periodic central monitoring of aggregate data at study, region, country, site, and patient levels
• Lead risk review meetings, communicate findings, and facilitate root cause identification and mitigation strategies
• Ensure corrective and preventive actions are documented, assigned, and implemented
• Monitor the effectiveness of risk mitigation actions and recommend adjustments
• Create signal and trending reports for study teams
• Partner with the Adaptive Monitoring Excellence team on targeted source data verification and source data review
• Maintain accurate RBQM documentation
• Support internal and external audits, inspections, and regulatory interactions
• Maintain quality, consistency, and compliance with RBQM procedures across studies
• Adjust RBQM plans based on feedback and data-driven trends
• Identify and share best practices, case studies, failures, and process improvement opportunities
• Act as a change agent, champion, subject matter expert, and point of contact for RBQM methodology
• May perform line management of junior staff within RBQM Operations

• Bachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experience
• Minimum of 6 years of experience in the pharmaceutical or CRO industry
• Minimum of 2 years of experience in Risk Based Quality Management
• Minimum of 2 years 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, ICH E6, ICH E8 (GCP)
• Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies, and Corrective Actions Preventive Actions
• Knowledge of RBQM IT systems or other data analytic systems
• Demonstrated ability to analyze data, identify patterns and make recommendations for improvement
• Demonstrated ability to effectively lead cross-functional team meetings
• Experience forming cross-functional collaborations; strong interpersonal skills
• Ability to influence without authority
• Pragmatic and willing to drive and support change
• Comfortable with ambiguity
• Excellent teamwork, organizational, interpersonal, and problem-solving skills
• Assertive and collaborative communication style
• Aptitude for data analytics; analytical mind
• Attention to detail and a critical thinker
• Ability to effectively communicate cross functionally with people of various levels
• Legal right to work in the country where the role is based

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways
• Legal right-to-work requirement for the country where the role is based
• Reasonable accommodations during the recruitment process