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Quality Compliance and Risk Management Specialist

hace 2 meses

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

As a Quality Compliance and Risk Manager 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 our company standards and Health Authorities expectations.

Key Responsibilities:
  • Support RDQ Risk Management: Manage risk documentation and governance structure, ensuring that risk management processes are executed with the highest quality.
  • Provide Guidance and Expertise: Offer guidance and expertise to Quality Assurance and business partners on risk identification, root cause analysis, lifecycle management, and risk documentation.
  • Proactively Identify Quality Risks: Ensure appropriate risk identification and management within RDQ, fostering a culture of collaboration and continuous improvement.
  • Support Governance and Process Enhancement: Enhance governance and processes for management of significant risks and issues in RDQ, seeking improvements and development of systems and tools to support the RDQ risk management process.
  • Develop and Deliver Training: Develop and deliver training to ensure adherence to risk management standards, fostering a culture of collaboration and continuous improvement.
  • Provide Good Practice Expertise: Offer Good Practice (GxP) expertise and guidance on process excellence and projects across R&D/RDQ.
  • Participate in Cross-Functional Initiatives: Participate in cross-functional initiatives to drive risk management excellence and performance quality.
Essential Requirements:
  • Bachelor's Degree: Bachelor's degree in Life Sciences or Business.
  • Excellent English Language Skills: Excellent English language skills (oral and written).
  • Significant Relevant Work Experience: Significant relevant work experience in Quality Risk Management.
  • Strong Background in GXP and Health Authority Regulations: Strong background in GXP and relevant Health Authority regulations.
  • Innovative Mindset and Continuous Improvement Skills: Innovative mindset and strong continuous improvement skills.
  • Effective Communication Skills: Effective communication skills across different audiences and organizational levels.
  • High Awareness of Trends: High awareness of trends and ability to proactively address needs based on external demands.
Desirable Requirements:
  • Experience in the Pharmaceutical Industry: Experience in the pharmaceutical industry or public health sector in Drug Development.
  • Experience Presenting to Senior Leaders: Experience presenting to and networking with senior leaders/stakeholders.