Quality Risk Management Strategist

1 month ago

Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full time

At F. Hoffmann-La Roche Gruppe, we're committed to fostering a culture of excellence in quality risk management. As a Quality Risk Management Strategist, you'll play a pivotal role in developing and operationalizing an integrated Quality Risk Management Plan (iQRMP) and associated risk mitigation and control strategies. Your expertise will be instrumental in conducting systematic data surveillance, providing processes for oversight of the overall risk and issue management processes, and fostering a culture of continuous improvement within the study teams.

The Opportunity

  • Operationalize the integrated Quality Risk Management Plan (iQRMP) to ensure effective implementation.
  • Drive the development and maintenance of technology solutions necessary for Quality Risk Management implementation within the organization, including in-house systems and potential external technologies.
  • Collaborate closely with Quality Risk Management Strategic Leads to ensure cross-functional alignment and coordinated strategy for critical-to-quality (CtQ) factors, risk control strategies, and risk mitigation activities.
  • Conduct data surveillance and issue management by defining consistent risk control strategies and acceptable risk limits in collaboration with study teams and Strategic Leads.
  • Lead centralized systematic data surveillance across studies, document surveillance activities, and assess control measure outputs for necessary mitigating actions.
  • Analyze data for meaningful trends, trigger mitigating actions, and identify potential issues for knowledge sharing across studies.
  • Support continuous improvement efforts by standardizing the knowledge management lifecycle, developing risk libraries, driving disease area level risk and monitoring strategy, and sharing relevant insights with Quality Risk Management Strategic Leads for alignment.

Who You Are

  • You have completed a bachelor's degree and bring over 5 years of experience in Quality Risk Management / Quality Risk Management processes, including awareness of industry strategy and direction, knowledge and understanding of ICH E8 and ICH E6 requirements.
  • You are proficient in data analysis tools (R, Python, JMP) for manipulating, analyzing large datasets, creating visualizations, and applying statistical methods (hypothesis testing, regression analysis, data modeling) to analyze clinical trial data.
  • Strong systems awareness including good knowledge of data pipelines, models and systems along with strong cross-functional inputs and dependencies contributing to end-to-end Quality Risk Management delivery.
  • Proven critical thinking and problem-solving skills, with a strong attention to detail to ensure data accuracy and the ability to effectively address complex issues in the Quality Risk Management role.
  • Strong communication, relationship management, and influencing skills, with the ability to facilitate decision-making and effectively communicate to support the Quality Risk Management strategy.

At Roche, we're dedicated to pushing the boundaries of healthcare. Our team of over 100,000 people across 100 countries is passionate about delivering exceptional care and making a meaningful impact. Join us in our mission to improve lives and advance healthcare.

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