RBQM Risk Surveillance Lead

The Risk-Based Quality Management (RBQM) Risk Surveillance Lead is responsible for driving the adoption of RBQM practice at 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 the 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. This role can be based in our offices in London, UK, Dublin, Ireland or Barcelona, Madrid, Spain. Please note that Novartis cannot sponsor visas for these locations. Relocation is not available for these locations. On-site expectation of 12 days per month/average 3 days per week in the office.

About The Role

• 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/visualisations are programmed and functioning per operational requirements in the RBQM system.
• Conduct periodic central surveillance of the aggregate data at the study and potentially program level, leveraging available analytics/visualisations in the RBQM system, to identify emerging risks and/or issues.
• Facilitate risk review meetings and discussions with study and potentially program team members to effectively communicate and discuss the 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 of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit.

Experience

• Bachelor’s Degree in a health-related, life science area, or equivalent combination of education, training, and work experience.
• Minimum of 4 years of experience in the pharmaceutical or CRO industry.
• Preferred minimum of 1 year 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 and 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.
• Supports a culture of continual improvement and innovation; promotes knowledge sharing.
• Ability to influence without authority.
• Thinks creatively; challenges the status quo.

Languages: English: fluent written and spoken.