Head of Clinical Quality Assurance

hace 2 semanas


Barcelona, Barcelona, España Innovative Medicines A tiempo completo
{"title": "Head Compliance CQA", "content": "About the Role

As the Head of Clinical Quality Assurance, you will be responsible for ensuring the highest quality standards in clinical processes, ensuring compliance 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 and implementing the strategy, mission, and purpose of RDQ.
  • Guide Quality System Owners and Business Process Owners in the development of a robust strategy for clinical process changes, considering interdependencies and guiding respective risk business owners in all aspects of risk management.
  • Collaborate closely with Business Process Owners to prepare for audits, actively participate, support formulating robust CAPA plans, and ensure comprehensive review and flawless implementation.
  • 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 pharmaceutical drug development.
  • Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development.
  • High learning agility, mentally quick, comfortable with complexity and diversity, and highly interested in continuous improvement.
  • Effectively collaborating with stakeholders at all levels of the organization with a possibility to inspire and motivate cross-functional teams to drive change and promote a culture of excellence.
About Novartis

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

", "lang_code": "en-US"}

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