Sterility Assurance Manager

Business unit
Produzione; Quality Unit
Sedi
Italia/Toscana
For our client, a leading pharmaceutical company, we are looking for:

Sterility Assurance Manager

The role will report directly to the Associate Director of Sterility Assurance and will oversee the daily activities of the Sterility Assurance team supporting the operations.

Responsibilities
 
  • Manage and develop the assigned team
  • Manage technical troubleshooting for non-conformities arising from day-to-day activities
  • Ensure the implementation of the Sterility Assurance program, managing the timely preparation/revision of protocols and ensuring proper execution in terms of operations, documentation, and data integrity requirements
  • Ensure coordination with operations, utilities, and micro-labs for sterility assurance-related activities (e.g., APS, Bioburden)
  • Maintain Sterility Assurance excellence in the field
  • Work in cross functional team and ensure effective communication is maintained between departments
  • Support the preparation for regulatory inspections and ensure readiness, contributing to the site inspection program

Requirements
  • Master’s Degree in a scientific field (Pharma, Biotech, Microbiology preferred)
  • Experience and good knowledge of aseptic process and Sterility Assurance
  • Previous experience as people manager
  • Fluent in English
Business unit
Produzione; Quality Unit
Sedi
Italia/Toscana