Risk Based Quality Management (RBQM) Surveillance Lead - Mississauga - ref. x39759819
Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.That’s what makes us Roche.
The RBQM Surveillance Lead plays a meaningful role in developing and operationalizing an integrated Quality Risk Management Plan (iQRMP) and associated risk mitigation and control strategies, 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 ideal candidate will bring a blend of capabilities, including ability to drive data driven analysis, strong collaboration across cross teams and a comprehensive approach to documentation and reporting to ensure study teams are following RBQM processes and associated regulatory requirements.
The Opportunity- Operationalize the integrated Quality Risk Management Plan (iQRMP) to ensure effective implementation.
- Drive the development and maintenance of technology solutions necessary for RBQM implementation within Roche, including in-house systems and potential external technologies.
- Collaborate 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.
- 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 RBQM Strategic Leads for alignment.
- 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.
Relocation benefits are not available for this job posting.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become 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. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.
As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely.If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.
Roche is an Equal Opportunity Employer.