Quality Manager, Quality Assurance

📋 Description

• Develop and maintain the internal Quality Risk Assessment methodology and a comprehensive Audit
• Lead Quality Assurance activities related to procurement processes and vendor oversight.
• Establish and manage mechanisms for ongoing compliance monitoring with applicable laws
• Partner closely with Vendor Management and operational teams to develop and implement risk-based
• Coordinate and contribute to internal system and vendor audits in accordance with the established
• Manage all pre-audit and post-audit activities, ensuring appropriate documentation, follow-up, and

🎯 Requirements

• A Bachelor's or Master's degree in biomedical sciences, natural sciences, health sciences, or
• At least 3 years of direct auditing experience in GCP and/or GVP environments.
• Experience conducting GCP audits, including investigational site, Trial Master File (TMF), and
• At least 2 years of experience managing audit programs, including developing and maintaining
• Experience with both GVP and GCP regulatory requirements, or a strong willingness to expand your
• Knowledge of relevant regulatory frameworks and quality standards, including ICH-E6, EU GVP, and

🎁 Benefits

• Opportunity to contribute to clinical research programs focused on rare diseases and oncology.
• Meaningful work supporting the development of safe and effective treatments for patients worldwide.
• Collaboration with an international team of specialists across clinical research
• A supportive and collaborative working environment that encourages professional growth and
• An inclusive workplace where different perspectives and contributions are valued.
• A culture built around quality, integrity, trust, agility, accountability, and collaborative