Quality Compliance and Risk Management Specialist

hace 4 semanas

Barcelona, Barcelona, España Innovative Medicines A tiempo completo

Job Summary

As a Quality Compliance and Risk Manager GCP/PV, you will play a key 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 Novartis standards and Health Authorities expectations.

About the Role

This is an exciting opportunity to join our team as a Quality Compliance and Risk Manager GCP/PV, where you will work closely with Research & Development (R&D) business, Quality Assurance (QA) and Enterprise Risk Management (ERM) risk teams, and quality partners to advocate a quality mindset and ensure Research & Development Quality (RDQ) risk management is executed with the highest quality.

Key Responsibilities

  • Support RDQ risk management within RDQ, including management of the risk documentation, governance structure, and support meetings.
  • Provide guidance and expertise to 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 RDQ.
  • Support the enhancement of the appropriate governance and processes for management of significant risks and issues in RDQ.
  • Continuously seek improvements and development of comprehensive systems and tools to support the RDQ 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 (e.g. training, lessons learned, regular meetings with internal and external partners/stakeholders).
  • 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.
  • High awareness of trends and ability to proactively address needs based on external demands.

Why Join Us

At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. If you are passionate about making a difference in the lives of patients and are looking for a challenging and rewarding career opportunity, we encourage you to apply.

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