Senior Quality Compliance and Risk Manager
hace 4 semanas
About the Role:
We are seeking a highly experienced Senior Quality Compliance and Risk Manager (GCP/PV) Leader to join our team at Innovative Medicines. As a key member of our Quality Risk Management team, you will be responsible for providing expert guidance and support to ensure that our risk management processes and governance are fit for purpose and meet Novartis standards and Health Authorities' expectations.
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).
- Provide 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.
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 and experience in GXP and relevant Health Authority regulations, paired with a 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
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