Quality Risk Manager

2 weeks ago

Dublin, Dublin City, Ireland beBeeRisk Full time €75,000 - €105,000

The Risk-Based Quality Management (RBQM) Risk surveillance role is responsible for driving the adoption of RBQM practice at trial level and overseeing its implementation and continuous improvement. This professional works within a matrix environment, with overall accountability for the surveillance of quality risks across assigned trials and programs.

Key Responsibilities
  • Foster trial protocol risk assessment across multiple cross-functional domains, associated with critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs) and mitigation strategies.
  • Responsible for drafting, maintaining, and archiving study-specific documentation of risk management activities, such as Integrated Quality Risk Management Plans (IQRMP).
  • Partner with the RBQM system configuration team to ensure risk indicators, quality tolerance limits, and analytics/visualizations are programmed and functioning according to 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 issues.
  • Facilitate risk review meetings and discussions with study and potentially program team members to effectively communicate findings, support robust root cause identification, and encourage mitigation strategies.
  • Support internal and external audits and inspections.
  • Collaborate with training departments to support training initiatives and promote 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.

Requirements

  • Bachelor's Degree in a health-related or life science area, or equivalent combination of education, training, and work experience.
  • Minimum 4 years of experience in the pharmaceutical or Contract Research Organization (CRO) industry.
  • Preferred minimum 1 year of experience in Risk-Based Quality Management.
  • Rigorous understanding of the drug development process and clinical trial execution.
  • Knowledge of 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, and mitigation strategies.
  • 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 lead cross-functional team meetings effectively.
  • 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.
About Us

We offer a dynamic work environment that fosters collaboration, innovation, and growth. Our commitment to excellence drives us to deliver high-quality results and push boundaries in the field of drug development.

Join Our Community

If you are passionate about making a difference in the lives of patients and their families, we invite you to join our community of professionals dedicated to advancing medical science and improving human health.

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