Offer summary
Qualifications:
Bachelor’s degree in pharmaceutical life sciences, Minimum 8 years experience in pharma Quality and Compliance, Direct experience managing GxP systems (LMS, Veeva Vault), Experience in Audits, Risk Mitigation, Project management, Knowledge of US and European Guidelines in the Pharma Industry.
Key responsabilities:
- Establish/training systems, lead Electronic Document Management System
- Manage audit/inspections programs, product complaint management, QMS
- Support Information Technology initiatives, Health Authority inspections...
- Serve as SME during regulatory inspections, oversee risk registers/mitigation
- Prepare for corporate/health authority inspection-readiness programs