Risk Based Quality Management (RBQM) Surveillance Lead

Roche; Welwyn; On-site; CAD 80,000 - 100,000; Full time

Job summary

Join Roche as a Risk Based Quality Management Surveillance Lead, where you'll develop and implement quality risk management plans, conduct data analysis, and foster a culture of continuous improvement within clinical trials. This role requires strong analytical skills and experience in RBQM processes, with a focus on enhancing clinical trial quality and innovation.

Qualifications

• 3-5 years of experience in RBQM/RBM processes.
• Knowledge of ICH E8 and ICH E6 requirements.

Responsibilities

• Develop and operationalize an integrated Quality Risk Management Plan.
• Conduct data surveillance and identify risk signals.
• Support continuous improvement efforts by standardizing knowledge management.

Skills

Data Analysis

Critical Thinking

Problem Solving

Communication

Education

Bachelor's Degree

Tools

R

Python

JMP

Job description

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. 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.

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, you'll 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, you'll 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. We're in search of a dynamic individual with exceptional data-driven analysis skills, who thrives in collaborative environments and excels in cross-functional 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 in-house systems and potential external technologies.

• Collaborate closely with RBQM Strategic Leads and Surveillance 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 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 bachelor's degree and bring over 3-5 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.

Relocation benefits are not available for this job posting.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 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 life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.