Quality Compliance and Risk Management Specialist

hace 5 días


Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo

Job Summary:

As a Quality Compliance and Risk Management Specialist at Novartis Farmacéutica, 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 meet Novartis standards and Health Authorities' expectations.

About the Role:

Though there is a preference for pharmaceutical knowledge, applications with relevant Risk experience from other disciplines are welcome.

Key Responsibilities:

  • Support Research and Development Quality (RDQ) risk management, including management of the risk documentation and governance structure.
  • Provide guidance and expertise to Quality Assurance 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.
  • Support the enhancement of governance and processes for management of significant risks and issues in RDQ.
  • Continuously seek improvements and develop 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 GxP expertise and guidance on process excellence across Research and Development/RDQ.
  • Participate in cross-functional initiatives to drive risk management excellence and innovation.

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, paired with good business understanding.
  • Ability to be innovative when faced with opportunities or challenges.
  • Strong continuous improvement mindset and 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.


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