Quality Compliance And Risk Manager (Gcp/Pv) Manager

Quality Compliance and Risk Manager (GCP/PV)Job ID: 394206BR
Date: Jul 31, 2024
Location: Spain (Barcelona, London, or Dublin)
SummaryAs the Quality Compliance and Risk Manager for Good Clinical Practice / Pharmacovigilance (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 to advocate a quality mindset and ensure that 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 identification, awareness, and management.Enhance governance and processes for management of significant risks and issues in RDQ.Develop and deliver training to ensure adherence to risk management standards.Provide GxP expertise and guidance on process excellence and projects related to GxP regulations and standards.Participate in strategic initiatives to drive risk management excellence and performance.Essential Requirements: Bachelor's degree in Life Sciences or Business.Excellent English language skills (oral and written).Significant relevant work experience in Quality Risk Management.Strong background in GXP and relevant Health Authority regulations.Innovative mindset when faced with opportunities or challenges.Strong continuous improvement mindset with effective change management skills.Excellence in communication across different audiences and organizational levels.High awareness of trends and ability to proactively address needs based on external demands.Desirable Requirements: Experience in the pharmaceutical industry or public health sector in Drug Development.Experience presenting to and networking with senior leaders/stakeholders.Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives. We believe that our associates drive us each day to reach our ambitions. Join us in this mission!
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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