Senior Quality Assurance Professional

hace 2 semanas


Barcelona, Barcelona, España Novartis A tiempo completo
About Novartis

At Novartis, our purpose is to reimagine medicine to improve and extend people's lives. Our vision is to become the most valued and trusted medicines company in the world.

Estimated Salary: $120,000 - $180,000 per year

This role requires a Master's degree in Life Science/Pharm.D., M.D. or Ph.D. or MBA desired. The ideal candidate will have at least 10 years of involvement in regulated activities (GCP/PV), clinical development and/or QA positions in pharmaceutical drug development.

About the Role

As the primary quality contact for Business Process Owners (BPOs) in Development, you will ensure compliance with Health Authorities requirements and internal standards while driving continuous clinical process enhancements. You will lead quality initiatives, manage quality risks, and oversee quality issue management across Development Units and therapeutic areas.

Main Responsibilities:
  • Actively drive a culture of Quality and successfully embed a Quality mindset across Development by forging strong business partnerships, positively impacting business deliverables, and effectively implementing the strategy, mission, and purpose of RDQ.
  • Collaborate closely with BPOs to conduct regulatory requirements gap assessments and implement necessary actions to address any identified gaps.
  • 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.
  • Establish and diligently manage comprehensive reviews of quality and compliance-related topics within the relevant clinical business process area.
Requirements:
  • Master's degree in Life Science/Pharm.D., M.D. or Ph.D. or MBA desired.
  • At least 10 years of involvement in regulated activities (GCP/PV), clinical development and/or QA positions 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.
  • Ability to present to senior management, corporate functions and local executive team members, as well as to external audiences, health authorities and government officials.

The salary range is based on the location in Barcelona or Madrid, Spain, or London, England / Dublin, Ireland.



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