Global Quality Management Systems Lead

hace 4 días

Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo
About the Role

We are seeking a highly experienced and skilled professional to lead our Global Quality Management Systems (QMS) function. As a key member of our team, you will be responsible for establishing and maintaining a robust QMS network that aligns with our company's quality principles and regulatory requirements.

Key Responsibilities
  • Establish and maintain a global QMS network that ensures compliance with GCP, GLP, and GVP regulations and guidelines.
  • Drive interactions with cross-functional teams, including GDD, TRD, Country, GMA, NIBR, and Regulatory Affairs, to ensure effective governance and collaboration.
  • Represent global QMS at various boards and meetings, ensuring feedback from the network is incorporated into global initiatives and projects.
  • Act as a key point of contact for GDD, TRD, PV, GMA, NIBR associates on QMS-related topics and serve as a liaison partner in other initiatives and meetings.
  • Collaborate with process owners to ensure GxP compliance of processes and tools within your remit.
  • Author and review QMS documentation, including process descriptions and regulatory assessments.
  • Lead and participate in key QMS projects and initiatives, 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, as well as health authority expectations and industry trends.
  • Leadership and project management skills to ensure successful implementation of projects and initiatives.
  • Fluency in English, both written and spoken, with additional languages a plus.
About Novartis

At Novartis, we are committed to improving and extending people's lives through innovative science and bold innovation. We believe that our employees are the driving force behind our success, and we strive to create an inclusive and collaborative work environment that fosters growth and development.

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