Quality Manager, Quality Assurance

📋 Description

• Develops and maintains the internal Quality Risk Assessment methodology
• Develops and maintains a comprehensive Audit Universe
• Leads Quality Assurance activities in relation to procurement and vendor oversight
• Develops, maintains, and manages mechanisms that assure ongoing monitoring and compliance with all
• Partners closely with Vendor Management and operations teams, driving risk-based and compliant
• Coordinates and contributes to internal system and/or vendor audits initiated by the Company

🎯 Requirements

• Bachelor’s or Master’s degree in biomedical sciences, natural sciences, health sciences, or another
• Experience with both GVP and GCP regulatory requirements, or willingness to broaden expertise
• At least 3 years of direct auditing experience in GCP (e.g., investigational sites, TMFs, Vendors)
• At least 2 years of experience in audit program management including development and maintenance of
• Organization skills
• Attention to details