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 a willingness to broaden your 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 the development and
• Skills: Organization skills, attention to details, excellent communication and facilitation skills