We are looking for a Global Corporate Regulatory Quality Assurance Compliance Specialist for a pharmaceutical company

The purpose of this role is to guarantee compliance through coordination, support and overview for Global Regulatory and Local Regulatory Affairs Affiliates within their activities and integration in the Corporate systems. Managing and coordinate contracts with Third Parties. Purpose of this role is also to ensure and support the overall compliance and management of Corporate Global Compliance system.

Other point of the job is to coordinate and guarantee correct adherence and managing possible non-compliance in Computerized Systems with GxP impact


  • To manage the Global Regulatory and Local Regulatory Affairs Affiliates:
    • To integrate and guide European and Extra European Affiliates in the Corporate Compliance Systems
    • To give proper trainings and support in activities
    • To overview Regulatory and departments activities
    • To coordinate and support Affiliates in preparation of Health Authorities Inspections and audits received from third parties, if required the check can be performed on site
    • To issue metrics in order to extrapolate data and to update upper management
  • To manage related third parties:
    • To manage and overview contracts with Global Compliance Third Parties
    • To guarantee suitability of parties to the delegated activities
    • To conduct or participate to Third Parties audits
  • To coordinate and guarantee compliance with GxP requirements for Corporate Computerized System (e.g.EDMS)
    • Issue or review Validation documentation
    • Manage required change control to guarantee compliance and improvements of Global Compliance computerized Systems
    • Coordinate and oversight consultant and third parties that can be involved validation activities
  • Other Activities performed by Global Regulatory QA compliance can be:
    • Issue, update Corporate SOPs, Policies and Work Instruction related to Global Compliance in accordance with ITF needs and Health Authorities requirements
    • To support Corporate Functions in the issuing or update of their applicable Quality Documentation
    • To identify, check of QA KPIs and in calculation of Global Compliance Functions metrics.
    • To collaborate with the Global Compliance on risk analysis activities for audits prioritization before to submit the results to Corporate and Global Heads
    • To manage or support the management of Deviations/ CAPA/Change until closing, through the electronic Document Management System (eDMS), as applicable
    • To collaborate with Global Compliance Head in the preparation of the Regulatory Authorities’ Inspections and ensure the necessary assistance to inspectors during the inspections
    • To support Global Compliance during any type of Regulatory Audit.
    • To be constantly updated on industry regulations and quality news.


  • Bachelor’s degree in Life Sciences /Sciences/ Biomedical matters
  • At least 5 year of relevant experience in Quality Assurance area
  • Good English proficiency
  • Use computer tools (PC, E-mail, Office Package, Internet)
  • Flexibility
  • Initiative / Proactivity
  • Planning, organizing, controlling


Milan – Northern Area