At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

A healthier future. Its 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.

Thats what makes us Roche.

Join our clinical trial team as a Risk Based Quality Management (RBQM) Surveillance Lead! With multiple exciting opportunities available we are eager to welcome dynamic and curious individuals to our Global Product Development Quality organization at our Welwyn United Kingdom and/or Mississauga Canada offices.

In this pivotal role youll take the helm in both developing and operationalizing an integrated Quality Risk Management Plan (iQRMP) while spearheading effective risk mitigation and control strategies. As the RBQM Surveillance Lead youll be tasked with conducting detailed and systematic data surveillance managing overall risk and issue processes and fostering a culture of continuous improvement within study teams. Were in search of a dynamic individual with exceptional datadriven analysis skills who thrives in collaborative environments and excels in crossfunctional team settings. Your comprehensive approach to documentation and reporting will ensure strict adherence to RBQM processes and regulatory requirements pushing the boundaries of excellence in clinical trials. Step into this exciting and critical role to make a substantial impact on clinical trial quality and innovation!

The Opportunity:

• Operationalize the integrated Quality Risk Management Plan (iQRMP) to ensure effective implementation.

• Contribute to the development and maintenance of technology solutions necessary for RBQM implementation within Roche including inhouse systems and potential external technologies.

• Collaborate closely with RBQM Strategic Leads and Surveillance Leads to ensure crossfunctional alignment and coordinated strategy for criticaltoquality (CtQ) factors risk control strategies and risk mitigation activities.

• Conduct data surveillance and identify risk signals through oversight of definedt risk control strategies and acceptable risk limits in collaboration with study teams and Strategic Leads.

• Analyze data across studies for meaningful trends trigger potential process improvements or standardization of risk 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.

Who you are:

• You have completed a bachelors degree and bring over 35 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 crossfunctional inputs and dependencies contributing to end to end RBQM delivery.

• Proven critical thinking and problemsolving 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 decisionmaking and effectively communicate to support the RBQM strategy.

Relocation benefits are not available for this job posting.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver lifechanging healthcare solutions that make a global impact.

Lets build a healthier future together.