Join to apply for the Risk Surveillance Lead role at Novartis Ireland2 days ago Be among the first 25 applicantsJoin to apply for the Risk Surveillance Lead role at Novartis IrelandGet AI-powered advice on this job and more exclusive features.SummaryThe Risk-Based Quality Management (RBQM) Risk surveillance Lead is responsible driving the adoption of RBQM practice at trial level and oversee the implementation, and continuous improvement. Risk Surveillance Lead works within a matrix environment and has overall account-ability for the surveillance of the quality risks across the assigned trials and program, enabling a comprehensive clinical quality (GCP) risk governance. The role demonstrates leadership in influencing and improving clinical trial quality through the expert understanding of clinical trial protocols, processes, regulatory requirements, and quality management principles.SummaryThe Risk-Based Quality Management (RBQM) Risk surveillance Lead is responsible driving the adoption of RBQM practice at trial level and oversee the implementation, and continuous improvement. Risk Surveillance Lead works within a matrix environment and has overall account-ability for the surveillance of the quality risks across the assigned trials and program, enabling a comprehensive clinical quality (GCP) risk governance. The role demonstrates leadership in influencing and improving clinical trial quality through the expert understanding of clinical trial protocols, processes, regulatory requirements, and quality management principles.This role can be based in our offices in Dublin, Ireland or Barcelona, Spain. On site expectation of three days in the office.About The RoleMajor Accountabilities:Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evaluation of risks based on likelihood, detectability, impact, and ensures mitigation strategy / plans are definedResponsible for drafting, maintaining, and archiving the study specific documentation of risk management activities e.g., Integrated Quality Risk Management Plan (IQRMP)Partners with the RBQM system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM systemConduct of periodic central surveillance of the aggregate data at the study and potentially program level, leveraging available analytics/visualizations in the RBQM system, to identify emerging risks and/or issuesFacilitate risk review meetings and discussions with study and potentially program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategiesSupports and participates in internal and external audits and inspectionCollaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach.Identifies and shares lessons learned, best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processesActs as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefitExperienceBachelor’s Degree in a health-related, life science area, or equivalent combination of education, training, and work experienceMinimum of 4 years of experience in the pharmaceutical or CRO industryPreferred minimum of 1 years of experience in Risk Based Quality ManagementRobust understanding of the drug development process and clinical trial executionKnowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive ActionsKnowledge of RBQM IT systems or other data analytic systemsDemonstrated ability to analyze data, identify patterns and make recommendations for improvementDemonstrated ability to effectively lead cross functional team meetingsExperience forming cross-functional collaborations; strong interpersonal skillsSupports a culture of continual improvement and innovation; promotes knowledge sharingAbility to influence without authorityThinks creatively; challenges the status quoLanguagesEnglish: fluent written and spokenWhy Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureJoin our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/networkBenefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewardsSeniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionOtherIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Novartis Ireland by 2xGet notified about new Lead jobs in Dublin, County Dublin, Ireland.Dublin, County Dublin, Ireland 3 days agoDublin, County Dublin, Ireland 1 month agoDublin, County Dublin, Ireland 3 weeks agoCustomer Success Manager (Spanish Speaking)Dublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 3 weeks agoBusiness Training & Development Lead - Small and Medium BusinessDublin, County Dublin, Ireland 3 days agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 2 days agoEmployee Relations Specialist - EMEA - DublinDublin, County Dublin, Ireland 4 days agoDublin, County Dublin, Ireland 3 months agoDublin, County Dublin, Ireland 1 week agoCustomer Service Team Lead (Italy, Nordics)Dublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 6 months agoSenior Talent Learning and Development ManagerDublin, County Dublin, Ireland 1 month agoGunnocks, County Meath, Ireland 2 months agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 1 week agoDIOR, Team Lead, Part Time (30 hours), PermanentDublin, County Dublin, Ireland 4 months agoDublin, County Dublin, Ireland 3 months agoDublin, County Dublin, Ireland 1 week agoDeputy Store Manager - Dublin City CentreDublin, County Dublin, Ireland 1 week agoDublin, County Dublin, Ireland 2 days agoEMEA Employee Relations - Employment InvestigatorDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 2 weeks agoDublin, County Dublin, Ireland 6 days agoDublin, County Dublin, Ireland 2 weeks agoWe’re unlocking community knowledge in a new way. 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