Quality Risk Management Specialist
4 weeks ago
At F. Hoffmann-La Roche Gruppe, we prioritize diversity, equity, and inclusion, reflecting the communities we serve. In the realm of global healthcare, diversity is crucial for success. We believe that understanding diverse healthcare needs is essential, and we celebrate individuality while sharing a commitment to outstanding care.
Position OverviewOur mission is to innovate for a healthier future, ensuring that everyone has access to the healthcare they require, both now and for future generations. We strive to create an environment where individuals can spend more time with their loved ones. This is the essence of Roche.
The role of the RBQM Surveillance Lead is pivotal in crafting and executing an integrated Quality Risk Management Plan (iQRMP) along with relevant risk mitigation and control strategies. This position involves systematic data surveillance, overseeing risk and issue management processes, and nurturing a culture of continuous improvement within study teams. The ideal candidate will possess a unique combination of skills, including the ability to conduct data-driven analyses, foster collaboration across teams, and maintain comprehensive documentation and reporting to ensure adherence to RBQM processes and regulatory standards.
Key Responsibilities
- Implement the integrated Quality Risk Management Plan (iQRMP) to ensure successful execution.
- Develop and maintain technological solutions essential for RBQM implementation, including internal systems and potential external technologies.
- Work closely with RBQM Strategic Leads to guarantee cross-functional alignment and a coordinated strategy for critical-to-quality (CtQ) factors, risk control strategies, and risk mitigation efforts.
- Oversee data surveillance and issue management by establishing consistent risk control strategies and acceptable risk thresholds in collaboration with study teams and Strategic Leads.
- Lead centralized systematic data surveillance across studies, document surveillance activities, and evaluate control measure outputs for necessary corrective actions.
- Analyze data to identify significant trends, initiate mitigating actions, and share insights 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 RBQM Strategic Leads for alignment.
Candidate Profile
- A bachelor's degree with over 5 years of experience in RBQM/RBM processes, along with knowledge of industry strategies and 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 to clinical trial data.
- Strong systems awareness, including knowledge of data pipelines, models, and systems, along with the ability to manage cross-functional inputs and dependencies that contribute to comprehensive RBQM delivery.
- Demonstrated critical thinking and problem-solving abilities, with meticulous attention to detail to ensure data accuracy and effectively address complex issues in the RBQM domain.
- Excellent communication, relationship management, and influencing skills, with the capacity to facilitate decision-making and effectively convey information to support the RBQM strategy.
Note: Relocation benefits are not available for this position.
About UsAt Roche, over 100,000 individuals across 100 countries are dedicated to advancing healthcare. Our collaborative efforts have established us as one of the leading research-focused healthcare organizations globally. Our success is rooted in innovation, curiosity, and diversity.
Roche Pharma Canada is committed to fostering a vibrant and collaborative work environment that reflects our innovative culture.
Roche is an Equal Opportunity Employer.
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