Head of Clinical Quality Assurance

hace 4 semanas


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

We are seeking a highly skilled and experienced professional to join our team as Head, Compliance Clinical QA. As a key member of our Development Team, you will be responsible for ensuring the quality and compliance of our clinical processes, in line with Health Authorities requirements and internal standards.

Key Responsibilities
  • Drive a culture of quality and embed a quality mindset across Development by forging strong business partnerships.
  • Guide Quality System Owners and Business Process Owners in the development of a robust strategy for clinical process changes.
  • Collaborate closely with Business Process Owners to prepare for audits, actively participate, and support formulating robust CAPA plans.
  • Collaborate with the Head GCP Inspection Management and GCP Inspection Project Manager(s) during GCP Health Authority Inspections.
  • Guide Business Process Owners in preparing for specific presentations and deliverables requested during inspections.
  • Proactively address potential gaps and risks while identifying valuable opportunities for continuous improvement.
Requirements
  • Master's degree in life sciences / healthcare, M.D, Ph.D or MBA is desired.
  • At least 10 years of involvement in regulated activities (GCP/PH), clinical development and/or QA position in the pharmaceutical drug development.
  • Broad understanding of global expectations of Health Authorities in Clinical Development.
  • High learning agility and interest in continuous improvement.
  • Effectively collaborating with stakeholders at all levels of the organization.
  • Ability to present to Novartis senior management and external audiences.
  • Proficient English language skills.
About Novartis

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.



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