Risk Management Specialist

4 days ago

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

We are seeking a highly skilled Risk Management Specialist to join our team at Roche. As a key member of our Quality Assurance department, you will play a critical role in developing and implementing an integrated Quality Risk Management Plan (iQRMP) to ensure effective risk mitigation and control strategies.

Your primary responsibilities will include:

  • Developing and maintaining technology solutions necessary for RBQM implementation within Roche, including in-house systems and potential external technologies.
  • Collaborating closely with RBQM Strategic Leads to ensure cross-functional alignment and coordinated strategy for critical-to-quality (CtQ) factors, risk control strategies, and risk mitigation activities.
  • Conducting data surveillance and issue management by defining consistent risk control strategies and acceptable risk limits in collaboration with study teams and Strategic Leads.
  • Leading centralized systematic data surveillance across studies, documenting surveillance activities, and assessing control measure outputs for necessary mitigating actions.
  • Analyzing data for meaningful trends, triggering mitigating actions, and identifying potential issues for knowledge sharing across studies.
  • Supporting 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 RBQM Strategic Leads for alignment.

Requirements

  • You have completed a bachelor's degree and bring over 5 years of experience in RBQM / RBM 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 RBQM 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 RBQM role.
  • Strong communication, relationship management, and influencing skills, with the ability to facilitate decision-making and effectively communicate to support the RBQM strategy.

About Roche

At Roche, we are committed to pushing the boundaries of healthcare innovation. With over 100,000 employees across 100 countries, we are one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario, and employs over 850 employees. Our facility is a vibrant and collaborative environment that fosters teamwork and innovation.

We are an Equal Opportunity Employer and are committed to diversity and inclusion in the workplace.

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