Quality Assurance Manager for Clinical and Pharmacovigilance

il y a 4 semaines


Paris, Île-de-France Santen Temps plein
Job Summary

Santen is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for assisting with Clinical quality and Pharmacovigilance/Safety vigilance—quality processes oversight in Santen SAS, EMA, and APAC regions.

Key Responsibilities
  • Assist with oversight of Quality and compliance with clinical development projects, products, and programs.
  • Work in collaboration with the Clinical Department, Pharmacovigilance/Safety Vigilance EMEA, APAC, and other functional areas as needed on the implementation of the Santen Quality Management System.
  • Provide guidance to Clinical Operations, Data Management, clinical supply, and Drug Safety to develop their self-inspection activities.
  • Support Clinical Operations with quality-related issues and provide guidance when necessary.
  • Ensure patient safety and rights in compliance with applicable regulations by providing continuous support to clinical teams during the project lifecycle.
Requirements
  • Minimum of 10+ years' experience in Clinical Quality Assurance and/or GPvP Assurance.
  • Bachelor's degree in the scientific field or related healthcare provider (i.e., RN, Pharmacist PharmD). Advanced degree is a plus.
  • Excellent understanding and practical application of domestic and foreign regulations and requirements regarding GCP and GPvP.
  • Demonstrated experience preparing for regulatory inspections required.
  • Excellent technical knowledge of GCP QA, GPvP QA, and quality assurance techniques.
  • Strong interpersonal skills and the ability to work effectively in a cross-functional environment.
  • Excellent written/oral communication and presentation skills.
  • Strong organizational, time management, and project management skills.
  • Proficient in the Microsoft Office software suite and other relevant computer applications.
About Santen

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. We are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.



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