Director of Global Quality Management Systems

2 settimane fa


Italia Regeneron A tempo pieno

About the Role: We are seeking an exceptional professional to lead our Pharmacovigilance and Quality Management Systems team as an Associate Director. The ideal candidate will have a strong background in Pharmacovigilance/Drug Safety, Regulatory Affairs, or Quality Assurance within the pharmaceutical/biotech industry.

Responsibilities:

  • Develop and maintain the Pharmacovigilance Quality Management System in collaboration with subject matter authorities.
  • Coordinate the assignment of adverse event and product complaint training globally to vendors.
  • Create a comprehensive training program for all individuals within the GPS and relevant personnel involved in GVP.
  • Regularly review all procedures to ensure they accurately reflect the GPS activities being followed.
  • Monitor compliance with required training and address non-compliance by working with line management.
  • Lead initiatives to continuously improve the effectiveness and efficiency of GPS processes.
  • Maintain the AE-PC contract language and liaise with Legal, Procurement, and Commercial as needed to support contract review/update.

Requirements:

  • A minimum of 7+ years of experience in Pharmacovigilance/Drug Safety, Regulatory Affairs, or Quality Assurance within the pharmaceutical/biotech industry.
  • A Bachelor's degree is required.
  • Previous extensive knowledge and experience within Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
  • A consistent record of successful project management related to quality management.


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