Quality Assurance Manager in Pharmaceutical Affairs

il y a 4 semaines


Paris, Île-de-France Ultragenyx Pharmaceutical Temps plein

Quality Assurance Manager in Pharmaceutical Affairs

In collaboration with the Responsible Pharmacist and the Director of Pharmaceutical Affairs for France and Benelux, the Quality Assurance Manager will oversee the quality management system and ensure adherence to relevant pharmaceutical regulations within the French and Benelux regions. This role necessitates close cooperation with the European Qualified Person and Global Quality Assurance teams.

Key Responsibilities:

  • Oversee and uphold the Quality Management System
  • Ensure promotional activities align with established standards
  • Develop and execute audit plans, monitoring subcontractors engaged in pharmaceutical operations
  • Prepare for inspections and audits
  • Manage deviations, change controls, risk assessments, CAPAs, recalls, and product returns
  • Evaluate packaging materials and promotional materials
  • Facilitate training sessions for staff
  • Act as a support resource within the Pharmaceutical Affairs department

Qualifications:

  • Pharmacist qualification, with proficiency in both French and English
  • Certification as Deputy Responsible Pharmacist with a minimum of 2 years in this capacity
  • 5-10 years of experience in Quality Assurance
  • 6-12 months of experience in Pharmacovigilance
  • Familiarity with GxP standards and French and European regulations
  • Willingness to travel up to 20%

Company Benefits:

  • Generous vacation and public holiday policies
  • Long-term incentive and stock purchase programs
  • Employee wellness initiatives
  • Fitness reimbursement options
  • Tuition assistance
  • Professional development opportunities


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