Process Quality Assurance Specialist

hace 3 días


Barcelona, Barcelona, España Novartis A tiempo completo

**Job Description Overview**

We are seeking a Process Quality Assurance Specialist to join our team in Barcelona or Madrid, Spain. This role will be responsible for driving a culture of quality and excellence across Development by forging strong business partnerships, positively impacting business deliverables, and effectively implementing the strategy, mission, and purpose of RDQ.

About the Role

We have two positions available for this exciting opportunity. The ideal candidate will have excellent communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams. If you are a motivated and results-driven individual who is passionate about delivering high-quality results, we encourage you to apply.

Key Responsibilities:

  • Act as primary quality contact for Business Process Owners (BPOs) and actively engage with relevant RDQ representatives to provide comprehensive guidance.
  • Collaborate with BPOs to conduct regulatory requirements gap assessments and implement necessary actions to address any identified gaps.
  • Monitor and evaluate changes in regulations, best practices, and internal process working groups, and promptly initiate changes to clinical processes as applicable.
  • 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.
  • Collaborate closely with BPOs to prepare for audits, actively participate, support formulating robust CAPA plan, ensuring its comprehensive review and flawless implementation.
  • 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.

The estimated salary for this position is approximately €60,000-€80,000 per year, depending on experience.



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