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Associate Director, Development Unit Clinical Quality Assurance Lead

hace 2 meses


Barcelona, Barcelona, España Novartis Farmacéutica, S. A. A tiempo completo

Job Summary

We are seeking a highly experienced Associate Director, Development Unit Clinical Quality Assurance to provide strategic quality oversight on the entire Clinical Trial Process (CTP) for clinical trials under responsibility. As a key member of our Development Unit CQA team, you will ensure compliance with Health Authorities' requirements, internal standards, and patients' safety, rights, and well-being.

Key Responsibilities

  • Provide strong QA leadership to the business strategy for assigned trials, ensuring organization awareness and interrelationship of departments and business priorities.
  • Support the implementation of the quality strategy within GCT under responsibility, regularly monitoring the annual Quality Plan pertaining to the Clinical chapter.
  • Ensure adequate oversight of proactive quality risk management processes, including quality risk assessments and submission/inspection readiness activities.
  • Provide robust and clear quality oversight in various areas of clinical development, actively leveraging audit/inspection outcomes/trends to sustain improvement in clinical trials conduct.
  • Support continuous improvement initiatives and ensure that areas identified as weaknesses are properly addressed and executed for sustainability.

Requirements

  • Degree in Life Sciences, Pharmacy, or Medicines.
  • Extensive years of involvement in regulated activities (GCP/PV), clinical development, and/or QA positions.
  • Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development.
  • Sufficient years of proven experience in managing projects.
  • Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.

What We Offer

  • Competitive Salary.
  • Company Pension Plan.
  • Life and Accidental Insurance.
  • Flexible working hours.
  • Hybrid working model.
  • Subsidized dining facilities.
  • Employee recognition scheme.
  • Learning and development opportunities.

About Novartis

Our purpose is to reimagine medicine to improve and extend people's lives. We are committed to becoming the most valued and trusted medicines company in the world, and we believe that our people are the key to achieving this goal.