Clinical Process Excellence Manager

hace 4 semanas


Barcelona, Barcelona, España Novartis A tiempo completo
About this role:

As the primary quality contact for Business Process Owners (BPOs) in Development, you will ensure compliance with Health Authorities requirements and internal standards while driving continuous clinical process enhancements through a quality mindset.

Key Responsibilities:
  • Actively drive a culture of Quality and successfully embed a Quality mindset across Development by forging strong business partnerships, positively impacting business deliverables, and effectively implementing the strategy, mission, and purpose of RDQ.
  • Act as primary quality contact for Business Process Owners (BPOs) and actively engage with relevant RDQ representatives to provide comprehensive guidance on regulatory requirements and quality processes.
  • Collaborate with BPOs to conduct regulatory requirements gap assessments and implement necessary actions to address any identified gaps, ensuring adherence to Health Authorities requirements and internal standards.
  • Monitor and evaluate changes in regulations, best practices, and internal process working groups, and promptly initiate changes to clinical processes as applicable to maintain compliance and excellence.
  • Guide Quality System Owners (QSOs) and BPOs in the development of a robust strategy for clinical process changes, considering interdependencies and guide respective risk business owners in all aspects of risk management to ensure seamless quality oversight.
  • Collaborate closely with BPOs to prepare for audits, actively participate, support formulating robust CAPA plan, ensuring its comprehensive review and flawless implementation, and collaborate closely with the Head GCP Inspection Management and GCP Inspection Project Managers when a GCP Health Authority Inspection is announced.


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