Quality Compliance and Risk Management Specialist

hace 1 semana


Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo
{"h3": "Quality Compliance and Risk Manager (GCP/PV) Role Overview"}

As a Quality Compliance and Risk Manager GCP/PV at Novartis Farmacéutica, you will play a critical role in supporting 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.

About the Job

This is a hybrid onsite role, with a preference for pharmaceutical knowledge, but applications with relevant Risk experience from other disciplines are welcome.

Key Responsibilities:
  1. Support Research & Development Quality (RDQ) risk management, including management of risk documentation and governance structure.
  2. Provide guidance and expertise to Quality Assurance (QA) and business partners on risk identification, root cause analysis, lifecycle management, and risk documentation.
  3. Proactively identify quality risks to ensure appropriate risk awareness and management within RDQ.
  4. Support the enhancement of governance and processes for managing significant risks and issues in RDQ.
  5. Continuously seek improvements and development of comprehensive systems and tools to support the RDQ risk management process.
  6. Develop and deliver training to ensure adherence to risk management standards and foster a culture of collaboration.
  7. Provide Good Practice (GxP) expertise and guidance on process excellence across R&D/RDQ related to GxP regulations and standards.
  8. Participate in cross-functional initiatives to drive risk management excellence and performance quality.
Requirements:

To be successful in this role, you will need:

  1. Bachelor's degree in Life Sciences or Business
  2. Excellent English language skills (oral and written)
  3. Significant relevant work experience in Quality Risk Management
  4. Strong background in GXP and relevant Health Authority regulations
  5. Innovative mindset when faced with challenges
  6. Continuous improvement mindset with effective change management skills
  7. Excellent communication skills across various audiences
  8. High awareness of trends and ability to proactively address needs
Why Novartis?

At Novartis Farmacéutica, our purpose is to reimagine medicine to improve and extend people's lives. Join us in this mission to make a meaningful difference in the lives of patients and communities around the world.

Information about our benefits and rewards can be found in the Novartis Life Handbook.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams that represent the communities we serve.

Join our Novartis Network to stay connected and explore opportunities that match your skills and interests.

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