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Quality Compliance and Risk Management Specialist

hace 2 meses

Barcelona, Barcelona, España Novartis A tiempo completo
About the Role

As a Quality Compliance and Risk Manager at Novartis, you will play a critical role in supporting Regulatory Risk and Compliance by providing expertise and guidance to ensure that risk management processes and governance are fit for purpose and meet Health Authorities' expectations.

Key Responsibilities:
  • Support Research & Development (R&D) risk management within R&D, including management of risk documentation, governance structure, and support meetings.
  • Provide guidance and expertise to Quality Assurance (QA) and business partners on risk identification, root cause analysis, lifecycle management, and risk documentation to ensure robust risk management.
  • Proactively identify quality risks to ensure appropriate risk identification, awareness, and risk management within R&D.
  • Support the enhancement of governance and processes for management of significant risks and issues in R&D.
  • Continuously seek improvements and development of comprehensive systems and tools to support the R&D risk management process.
  • Develop and deliver training to ensure adherence to risk management standards.
  • Foster a culture of collaboration and capability building by delivering educational and learning preparations.
  • Provide Good Practice (GxP) expertise and guidance on process excellence and projects across R&D/RDQ related to GxP regulations and standards.
  • Participate in cross-functional/cross-divisional strategic initiatives to drive risk management excellence, performance excellence, quality, and innovation.
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 and experience in GXP and relevant Health Authority regulations, paired with good business understanding.
  • Ability to be innovative when faced with opportunities or challenges.
  • Strong mindset on continuous improvement with effective change management skills to sustain a culture of high ethical standards and compliance.
  • Excellence in communicating effectively across different audiences and organizational levels and the ability to bridge between quality, scientific, and business experts to form strong and effective relationships with partners.