Senior Quality Risk Management Strategist

7 days ago

Mississauga, Ontario, Canada Roche Full time

At Roche, we're committed to fostering a culture of diversity, equity, and inclusion, reflecting the communities we serve. To achieve this, we believe that inclusion is key to understanding people's varied healthcare needs. We're seeking a skilled Senior Quality Risk Management Strategist to play a meaningful role in developing and operationalizing an integrated Quality Risk Management Plan (iQRMP) and associated risk mitigation and control strategies.

The ideal candidate will bring a blend of capabilities, including the ability to drive data-driven analysis, strong collaboration across cross-functional teams, and a comprehensive approach to documentation and reporting. Key responsibilities will 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, and 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.

As a Senior Quality Risk Management Strategist, you will conduct data surveillance and issue management by defining consistent risk control strategies and acceptable risk limits in collaboration with study teams and Strategic Leads. You will also lead centralized systematic data surveillance across studies, document surveillance activities, and assess control measure outputs for necessary mitigating actions. Additionally, you will analyze data for meaningful trends, trigger mitigating actions, and identify potential issues for knowledge sharing across studies.

Key qualifications for this role include a 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. You should be 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, is also essential.

As a member of the Roche team, you will have the opportunity to work with a diverse group of professionals who share a passion for exceptional care. We offer a collaborative and dynamic work environment that fosters growth and development. If you're a motivated and detail-oriented individual with a strong background in quality risk management, we encourage you to apply for this exciting opportunity.

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