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Quality Compliance And Risk Manager
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Quality Compliance and Risk Manager (GCP/PV)Job ID: 394206BR
Location: Barcelona, London or Dublin
Type: Hybrid onsite, #LI-Hybrid
SummaryAs the Quality Compliance and Risk Manager GCP/PV, you will support Regulatory Risk and Compliance by providing expertise and guidance to ensure that the risk management process and governance meet Novartis standards and Health Authorities' expectations. You will engage with Research & Development (R&D) business, Quality Assurance (QA) and Enterprise Risk Management (ERM) risk teams, and quality partners to advocate a quality mindset and ensure Research & Development Quality (RDQ) risk management is executed with the highest quality.
About the RoleThough there is a preference for pharmaceutical knowledge, applications with relevant Risk experience from other disciplines are welcome.
Key Responsibilities: Support RDQ risk management, including management of risk documentation and governance structure.Provide guidance and expertise to QA and business partners on risk identification, root cause analysis, lifecycle management, and risk documentation.Proactively identify quality risks to ensure appropriate risk awareness and management within RDQ.Support the enhancement of governance and processes for managing significant risks and issues in RDQ.Continuously seek improvements and development of comprehensive systems and tools to support the RDQ risk management process.Develop and deliver training to ensure adherence to risk management standards and foster a culture of collaboration.Provide Good Practice (GxP) expertise and guidance on process excellence across R&D/RDQ related to GxP regulations and standards.Participate in cross-functional initiatives to drive risk management excellence and performance quality.Essential Requirements: Bachelor's degree in Life Sciences or BusinessExcellent English language skills (oral and written)Significant relevant work experience in Quality Risk ManagementStrong background in GXP and relevant Health Authority regulationsInnovative mindset when faced with challengesContinuous improvement mindset with effective change management skillsExcellent communication skills across various audiencesHigh awareness of trends and ability to proactively address needsDesirable Requirements: Experience in the pharmaceutical industry or public health sector, particularly in Drug DevelopmentExperience presenting to and networking with senior leaders/stakeholdersWhy Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives. Join us in this mission
You'll receive:
Information about our benefits and rewards can be found in the Novartis Life Handbook.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams that represent the communities we serve.
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