Risk Manager

2 weeks ago

Mississauga, Ontario, Canada Roche Full time

At Roche, we're committed to fostering a culture of innovation, curiosity, and diversity. Our success is built on the dedication of our employees, who work together to push back the frontiers of healthcare.

The RBQM Surveillance Lead plays a critical role in developing and operationalizing an integrated Quality Risk Management Plan (iQRMP) that ensures effective implementation. This involves driving the development and maintenance of technology solutions necessary for RBQM implementation within Roche, including in-house systems and potential external technologies.

Collaborating closely with RBQM Strategic Leads, the ideal candidate will ensure cross-functional alignment and coordinated strategy for critical-to-quality (CtQ) factors, risk control strategies, and risk mitigation activities. They will also conduct data surveillance and issue management by defining consistent risk control strategies and acceptable risk limits in collaboration with study teams and Strategic Leads.

Key responsibilities include:

  • Operationalizing the integrated Quality Risk Management Plan (iQRMP) to ensure effective implementation.
  • Driving the development and maintenance of technology solutions necessary for RBQM implementation within Roche.
  • 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.

Requirements:

  • Bachelor's degree and 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.
  • Proficiency 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.

We are an Equal Opportunity Employer and require all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. If you have a valid reason for not being fully immunized, you may request an exemption and/or adaptation measures regarding this vaccination requirement.

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