Quality Risk Management Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeRisk Full time €70,000 - €115,000
Job Overview

The Quality Risk Management Specialist is responsible for driving the adoption of RBQM practices at trial level and overseeing implementation, and continuous improvement.

This role involves a significant amount of time in an office setting.

Key Responsibilities:

  • Facilitate risk assessment across multiple cross-functional domains associated with CtQ data and processes, including definition of QTLs, evaluation of risks based on likelihood, detectability, impact, and ensure mitigation strategies/plans are defined
  • Responsible for drafting, maintaining, and archiving 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 aggregate data at the study and potentially 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 and potentially program team members to effectively communicate and discuss findings, support, and encourage robust root cause identification and mitigation strategies
  • Support 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

Requirements:

  • Bachelor's Degree in a health-related or 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

Language Skills:

English: fluent written and spoken

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