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Quality Risk Management Specialist

3 months ago

Welwyn SK, Canada Roche Full time

Roche is committed to fostering diversity, equity, and inclusion, reflecting the communities we serve. In the realm of global healthcare, diversity is crucial for success. We recognize that inclusion is vital for understanding the diverse healthcare needs of individuals. Together, we celebrate uniqueness and share a dedication to outstanding care. Join Roche, where every voice is valued.

Position Overview

Our drive for a healthier future inspires us to innovate continuously. We strive to advance science and ensure that everyone has access to the healthcare they require today and for future generations. We aim to create a world where we can spend more time with our loved ones. This is the essence of Roche.

The Quality Risk Management (QRM) Surveillance Lead plays a pivotal role in formulating and executing an integrated Quality Risk Management Plan (iQRMP) along with relevant risk mitigation and control strategies. This role involves conducting systematic data surveillance, establishing processes for overseeing overall risk and issue management, and nurturing a culture of ongoing improvement within study teams. The ideal candidate will possess a combination of skills, including the ability to conduct data-driven analyses, collaborate effectively across teams, and maintain a thorough approach to documentation and reporting to ensure compliance with QRM processes and regulatory standards.

Key Responsibilities
  • Implement the integrated Quality Risk Management Plan (iQRMP) to ensure successful execution.
  • Lead the development and upkeep of technological solutions essential for QRM implementation within Roche, encompassing both internal systems and potential external technologies.
  • Work closely with QRM Strategic Leads to ensure cross-functional alignment and a coordinated strategy for critical-to-quality (CtQ) factors, risk control strategies, and risk mitigation activities.
  • Conduct data surveillance and manage issues by defining consistent risk control strategies and acceptable risk thresholds in collaboration with study teams and Strategic Leads.
  • Oversee centralized systematic data surveillance across studies, document surveillance activities, and evaluate control measure outputs for necessary corrective actions.
  • Analyze data for significant trends, initiate mitigating actions, and identify potential issues for knowledge sharing across studies.
  • Support continuous improvement initiatives by standardizing the knowledge management lifecycle, developing risk libraries, driving disease area-level risk and monitoring strategies, and sharing relevant insights with QRM Strategic Leads for alignment.
Qualifications
  • A bachelor's degree and over 5 years of experience in QRM/RBM processes, with a solid understanding of industry strategies and guidelines, including ICH E8 and ICH E6 requirements.
  • Proficiency in data analysis tools (R, Python, JMP) for manipulating and analyzing large datasets, creating visualizations, and applying statistical methods (hypothesis testing, regression analysis, data modeling) to clinical trial data.
  • Strong systems awareness, including a good understanding of data pipelines, models, and systems, along with the ability to manage cross-functional inputs and dependencies contributing to end-to-end QRM delivery.
  • Proven critical thinking and problem-solving abilities, with a keen attention to detail to ensure data accuracy and effectively address complex issues in the QRM role.
  • Excellent communication, relationship management, and influencing skills, with the capability to facilitate decision-making and effectively convey information to support the QRM strategy.

Relocation benefits are not available for this position.

About Roche

At Roche, over 100,000 individuals across 100 countries are advancing the frontiers of healthcare. Together, we have established ourselves as one of the world's leading research-focused healthcare organizations. Our success is founded on innovation, curiosity, and diversity.

Roche Pharma Canada employs over 850 individuals and fosters a collaborative and vibrant workplace culture that reflects Roche's commitment to innovation.

Roche is an Equal Opportunity Employer.