Quality Compliance and Risk Manager
hace 6 días
About the Role
As a Quality Compliance and Risk Manager at Novartis Farmacéutica, you will play a crucial 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.
Key Responsibilities:
- Support Research and Development Quality (RDQ) risk management, including management of risk documentation, governance structure, and support meetings.
- 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 identification, awareness, and management within RDQ.
- Support the enhancement of governance and processes for management of significant risks and issues in RDQ.
- Continuously seek improvements and development of 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 Good Practice (GxP) expertise and guidance across Research and Development/RDQ related to GxP regulations and standards.
- Participate in cross-functional strategic initiatives to drive risk management excellence, performance excellence, quality, 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.
- Innovative mindset when faced with opportunities or challenges.
- Strong focus on continuous improvement 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 gained in the pharmaceutical industry or public health sector in Drug Development.
- Experience presenting to and networking with senior leaders/stakeholders.
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