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Global Quality Management Systems Lead

hace 2 meses

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

We are seeking a highly skilled Quality Assurance Manager to join our team at Innovative Medicines. As a key member of our Global Quality Management Systems team, you will be responsible for ensuring the development, implementation, and maintenance of our Quality Management Systems (QMS) across the organization.

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 global QMS at various boards and meetings, ensuring feedback from the network is incorporated into global initiatives and projects.
  • Act as a subject matter expert for selected Quality processes, ensuring GxP compliance and collaborating with QSO/Process owners to develop and maintain related IT systems.
  • Lead and participate in key QMS projects and initiatives, ensuring quality elements and compliance requirements are addressed.
Requirements:
  • University degree in Pharmacy, Chemistry, Engineering, or equivalent related discipline, preferably in Quality Systems.
  • 6+ years' experience in Pharmaceutical, Chemical, or Biological Operations, with a focus on QA processes and underlying regulatory requirements and industry standards.
  • Specific practical experience and expertise in both Clinical Operations and Regulatory Affairs.
  • Good understanding of Novartis QMS principles and senior expert-level understanding of GxP regulations and guidelines.