Global Quality Management Systems Lead

hace 1 semana

Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo
Job Summary

We are seeking a highly experienced and skilled Global Quality Management Systems Lead to join our team at Novartis Farmacéutica. As a key member of our organization, you will be responsible for establishing and running the Quality Management Systems (QMS) network for Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Vigilance Practices (GVP) areas.

Key Responsibilities
  • Establish and maintain the QMS network for GCP, GLP, and GVP areas, ensuring alignment with business functions and regulatory requirements.
  • Drive interactions with Global Development, Clinical Development, and Regulatory Affairs Functions through a defined governance model.
  • Represent global QMS at various boards and meetings, ensuring feedback from the network is incorporated into global initiatives and projects.
  • Act as the key point of contact for associates on QMS-related topics and collaborate with process owners to ensure GxP compliance.
  • Lead and participate in key QMS projects, ensuring defined 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.
  • Senior expert level understanding of GxP regulations and guidelines.
  • Leadership and Project Management skills to ensure successful implementation of projects.
Why Join Us?

At Novartis Farmacéutica, we are committed to improving and extending people's lives. We believe that the answers to this challenge are found when curious, courageous, and collaborative people like you are brought together in an inspiring environment. We offer opportunities to explore the power of digital and data, take smart risks, and be surrounded by people who share your determination to tackle the world's toughest medical challenges.

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