Senior Manager – RBQM Operations

This is a fully remote position, open to applicants in Brazil, +4 more countries.

📋 Description

• Execute and oversee RBQM procedures at the study level.

• Evaluate study protocols and assist in the creation of Study Risk Assessments that outline critical data, essential processes, and key risk indicators.

• Craft study-specific materials and lead training and kick-off meetings related to RBQM.

• Develop and implement study-specific RBQM plans.

• Facilitate risk assessment meetings with cross-functional study team members throughout the trial lifecycle.

• Collaborate with the RBQM system configuration team to ensure that risk indicators, quality tolerance limits, and analytics/visualizations operate effectively.

• Conduct periodic central monitoring of aggregate data at study, region, country, site, and patient levels.

• Lead risk review meetings, communicate findings, and aid in identifying root causes and mitigation strategies.

• Ensure that corrective and preventive actions are documented, assigned, and executed.

• Monitor the efficacy of risk mitigation actions and suggest necessary adjustments.

• Generate signal and trending reports for study teams.

• Collaborate with the Adaptive Monitoring Excellence team on targeted source data verification and review.

• Maintain precise RBQM documentation.

• Support internal and external audits, inspections, and regulatory interactions.

• Ensure quality, consistency, and compliance with RBQM procedures across all studies.

• Adjust RBQM plans based on feedback and data-driven trends.

• Identify and disseminate best practices, case studies, failures, and opportunities for process improvement.

• Serve as a change agent, advocate, subject matter expert, and primary contact for RBQM methodology.

• May oversee junior staff within RBQM Operations.

⛳️ Requirements

• Preferred Bachelor’s Degree in a health-related, life science field or an equivalent international qualification, or a comparable combination of education, training, and work experience.

• At least 6 years of experience in the pharmaceutical or CRO industry.

• Minimum of 2 years in Risk Based Quality Management.

• A minimum of 2 years in managerial and supervisory roles.

• Strong understanding of the drug development process and execution of clinical trials.

• Familiarity with industry regulatory standards including 21 CFR Part 11, ICH E6, and ICH E8 (GCP).

• Experience in risk management, sponsor audits, health authority inspections, root cause analyses, mitigation strategies, and Corrective Actions Preventive Actions.

• Knowledge of RBQM IT systems or other data analytics tools.

• Proven ability to analyze data, discern patterns, and provide recommendations for improvement.

• Track record of effectively leading cross-functional team meetings.

• Experience in forming cross-functional collaborations; strong interpersonal abilities.

• Capacity to influence without direct authority.

• Pragmatic approach and willingness to drive and support change.

• Comfortable navigating ambiguity.

• Exceptional teamwork, organizational, interpersonal, and problem-solving skills.

• Assertive yet collaborative communication style.

• Strong aptitude for data analytics and a critical thinking mindset.

• Attention to detail and ability to think critically.

• Competence in effectively communicating cross-functionally with individuals at various levels.

• Legal right to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development 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.