Head of Clinical Quality Assurance

hace 2 días


Barcelona, Barcelona, España Innovative Medicines A tiempo completo
Job Title: Head Compliance CQA

About the Role:

We are seeking a highly experienced and skilled professional to join our team as Head of Clinical Quality Assurance. As a key member of our Development Team, you will be responsible for ensuring the highest standards of quality and compliance in our clinical processes.

Key Responsibilities:

  • Drive a culture of quality and excellence across Development by forging strong business partnerships and implementing effective quality strategies.
  • Guide Quality System Owners and Business Process Owners in the development of robust clinical process changes, considering interdependencies and risk management.
  • Collaborate closely with Business Process Owners to prepare for audits, actively participate, and support the formulation of a robust CAPA plan.
  • Proactively address potential gaps and risks while identifying valuable opportunities for continuous improvement.
  • Drive continuous improvement through data-generated insights for clinical processes, fostering a culture of excellence.

Requirements:

  • Master's degree in life sciences/healthcare, M.D, Ph.D, or MBA.
  • 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 the area of Clinical Development and profound understanding of the science of product development.

About Us:

We are Innovative Medicines, a company driven by our purpose to reimagine medicine to improve and extend people's lives. We are committed to optimizing and strengthening our processes and ways of working, investing in new technologies, and building specific therapeutic areas and platform depth and capabilities.



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