Director of Compliance and Quality Assurance

1 giorno fa


Italia Regeneron A tempo pieno
About Regeneron

We are a leading biotech company committed to delivering innovative treatments and improving lives. Our diverse team is passionate about making a difference in the world of medicine.

Job Summary

We are seeking an experienced Associate Director to join our GPS Standards & Training team. As a key member of our team, you will play a crucial role in maintaining our Pharmacovigilance (PV) Quality Management System and ensuring compliance with regulatory PV requirements worldwide.

Responsibilities
  • Develop and maintain the PV Quality Management System in collaboration with subject matter authorities.
  • Coordinate adverse event and product complaint training globally for vendors.
  • Create comprehensive training programs for GPS personnel involved in Good Vigilance Practice.
  • Regularly review procedures to ensure they accurately reflect our activities.
  • Monitor compliance with required training and address non-compliance with line management.
  • Lead initiatives to improve process effectiveness and efficiency.
Requirements
  • 7+ years of experience in Pharmacovigilance/Drug Safety, Regulatory Affairs, or Quality Assurance within the pharmaceutical/biotech industry.
  • Bachelor's degree required.
  • Extensive knowledge and experience within Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
  • Proven track record of successful project management related to quality management.
What We Offer

We provide comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.

$140,000 - $170,000 per year, depending on experience and qualifications.

This role offers a competitive salary and opportunities for growth and development in a dynamic and inclusive environment.



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