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Global Quality Management Systems Lead

hace 2 meses

Barcelona, Barcelona, España Innovative Medicines A tiempo completo
About the Role

As a key member of the Innovative Medicines team, we are seeking a highly skilled and experienced Global Quality Management Systems professional to join our organization. This role will be responsible for ensuring the effective implementation and maintenance of our Quality Management Systems (QMS) across the globe.

Key Responsibilities
  • Establish and maintain a robust QMS network for GCP, GLP, and GVP areas, ensuring compliance with regulatory requirements and industry standards.
  • Collaborate with cross-functional teams, including GDD, TRD, Country, GMA, NIBR, and Regulatory Affairs, to drive QMS-related activities and initiatives.
  • Represent the global QMS function at various boards and meetings, ensuring feedback from the network is incorporated into global initiatives.
  • Act as a subject matter expert for selected Quality processes, ensuring GxP compliance and collaborating with QSO/Process owners.
  • Lead and participate in key QMS projects, ensuring quality elements and compliance requirements are addressed.
Requirements
  • University degree in Pharmacy, Chemistry, Engineering, or equivalent related discipline.
  • 6+ years' experience in Pharmaceutical, Chemical, or Biological Operations, with a focus on QA processes and regulatory requirements.
  • Specific practical experience and expertise in Clinical Operations and Regulatory Affairs.
  • Good understanding of Novartis QMS principles and senior expert-level understanding of GxP regulations and guidelines.