Quality Compliance and Risk Manager (GCP/PV) Job ID: 394206BR
Location: Barcelona, London or Dublin
Type: Hybrid onsite, #LI-Hybrid
Summary As Quality Compliance and Risk Manager GCP/PV, you will support Regulatory Risk and Compliance by providing expertise and guidance to ensure that risk management processes and governance meet Novartis standards and Health Authorities' expectations. You will engage with Research & Development (R&D) business, Quality Assurance (QA), and Enterprise Risk Management (ERM) risk teams 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 and governance structure.
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 awareness and management.
Support the enhancement of governance and processes for management of significant risks and issues in RDQ.
Continuously seek improvements and develop comprehensive 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 GxP expertise and guidance on process excellence across R&D/RDQ.
Participate in cross-functional initiatives to drive risk management excellence 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, paired with good business understanding.
Ability to be innovative when faced with opportunities or challenges.
Strong continuous improvement mindset 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 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, and our vision is to become the most valued and trusted medicines company in the world. Be a part of this mission and join us!
You'll receive:
You can find everything you need to know about our benefits and rewards 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.
Division: Development
Business Unit: Innovative Medicines
Location: Spain
Site: Barcelona Gran Vía
Company / Legal Entity: ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.
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