Quality Compliance and Risk Manager (GCP/PV) Manager Job ID: 394206BR
Jul 31, 2024
Location: Spain (Barcelona, London, or Dublin)
Summary As Quality Compliance and Risk Manager GCP/PV, you will support 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. You will engage with Research & Development (R&D) business, Quality Assurance (QA), 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.
About the Role Though there is a preference for pharmaceutical knowledge, applications with relevant risk experience from other disciplines are welcome.
Key Responsibilities:
Support RDQ risk management, 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.
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 R&D/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.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives. Join us in this mission!
You'll receive:
Information about our benefits and rewards can be found in the Novartis Life Handbook.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Novartis Network:
If this role is not suitable for you but you wish to stay connected, join the Novartis Network.
Division: Development
Business Unit: Innovative Medicines
Functional Area: Quality
Job Type: Full time
Employment Type: Regular
Shift Work: No
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