Quality Compliance and Risk Manager (GCP/PV)Job ID: 394206BR
Location: Spain (Barcelona, London, or Dublin)
Type: Hybrid onsite, #LI-Hybrid
SummaryAs Quality Compliance and Risk Manager GCP/PV, you will support Regulatory Risk and Compliance by providing expertise and guidance to ensure that risk management processes 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) teams 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 identification and management within RDQ.
• Support the enhancement of governance and processes for management of significant risks and issues in RDQ.
• Seek improvements and development of 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 and projects across R&D/RDQ.
• Participate in cross-functional initiatives to drive risk management excellence and performance quality.
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 and strong continuous improvement skills.
• Effective communication skills 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. Join us and be part of this mission!
You'll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
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.
Join our Novartis Network:
If this role is not suitable to your experience or career goals, join the Novartis Network to stay connected.
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