RBQM - Risk Surveillance Lead (Director/Assoc. Director) - Sponsor Dedicated

The Risk-Based Quality Management (RBQM) Risk Surveillance Lead is responsible for driving the adoption of RBQM practice at the trial level and overseeing the implementation and continuous improvement. The Risk Surveillance Lead works within a matrix environment and has overall accountability for the surveillance of quality risks across the assigned trials and program, enabling comprehensive clinical quality (GCP) risk governance. The role demonstrates leadership in influencing and improving clinical trial quality through expert understanding of clinical trial protocols, processes, regulatory requirements, and quality management principles.

Major Accountabilities

• Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory, etc.) associated with critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evaluation of risks based on likelihood, detectability, impact, and ensuring mitigation strategy/plans are defined.
• Responsible for drafting, maintaining, and archiving the study-specific documentation of risk management activities, e.g., Integrated Quality Risk Management Plan (IQRMP).
• Partner with the RBQM system configuration team to ensure risk indicators, quality tolerance limits, and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM system.
• Conduct periodic central surveillance of the aggregate data at the study and program level, leveraging available analytics/visualizations in the RBQM system to identify emerging risks and/or issues.
• Facilitate risk review meetings and discussions with study/program team members to effectively communicate and discuss findings, support, and encourage robust root cause identification and mitigation strategies.
• Support and participate in internal and external audits and inspections.
• Collaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach.
• Identify and share lessons learned, best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processes.
• Act as a change agent, champion, subject matter expert, and point of contact for RBQM methodology, leading study teams to understand and follow best practices to achieve maximum benefit.
• May perform line management of other (junior) staff within the RBQM Team.

Key Performance Indicators

• Adoption rate of RBQM across trial portfolio.
• Effectiveness in risk identification, assessment, and mitigation (number of risks identified, assessed, and successfully mitigated).
• Stakeholder satisfaction measured through structured feedback and surveys conducted periodically.
• Insights generated from metrics leading to process and quality risks improvements.

Qualifications

• Minimum of 6 years of experience in the pharmaceutical or CRO industry.
• Minimum of 2 years of experience in Risk-Based Quality Management.
• 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, health authority inspections, root cause analyses, and mitigation strategies as well as 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.
• Support a culture of continual improvement and innovation; promote knowledge sharing.
• Ability to influence without authority.
• Think creatively; challenge the status quo.