Head Quality Assurance Specialist

hace 4 semanas


Barcelona, Barcelona, España Novartis A tiempo completo
About the Role

We are seeking an experienced Head Process Quality professional to join our team at Novartis. The successful candidate will be responsible for ensuring compliance with Health Authorities' requirements and internal standards while driving continuous clinical process enhancements.

The primary quality contact for Business Process Owners (BPOs) in Development, you will lead quality initiatives, manage quality risks, and oversee quality issue management across Development Units and therapeutic areas. By partnering within CQA and RDQ, you will provide strategic QA/GxP expertise, ensuring exceptional quality, proactive compliance, and superior business satisfaction.

Key Responsibilities:
  • Cultivate a Culture of Quality: Drive a culture of excellence by forging strong business partnerships, positively impacting business deliverables, and effectively implementing the strategy, mission, and purpose of RDQ.
  • Provide Comprehensive Guidance: Act as primary quality contact for Business Process Owners (BPOs) and actively engage with relevant RDQ representatives to provide comprehensive guidance.
  • Risk Management: Collaborate with BPOs to conduct regulatory requirements gap assessments and implement necessary actions to address any identified gaps.
  • Regulatory Compliance: Monitor and evaluate changes in regulations, best practices, and internal process working groups, and promptly initiate changes to clinical processes as applicable.
  • Strategic Planning: 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.
  • Audit Support: Collaborate closely with BPOs to prepare for audits, actively participate, support formulating robust CAPA plan, ensuring its comprehensive review and flawless implementation.
  • Inspection Management: Collaborate closely with the Head GCP Inspection Management and GCP Inspection Project Managers when a GCP Health Authority Inspection is announced, promptly identifying potential risk areas that may impact the process.


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