As a Quality Assurance Manager at CatalYm, you will play a crucial role in ensuring the highest standards of quality and compliance in our clinical development programs. You will be a key driver in maintaining and improving our Quality Management System (QMS) and ensuring inspection readiness. Your responsibilities will include:

• Developing and Optimizing Quality Management Systems: support the development, maintenance and continuous improvement of Standard Operating Procedures, Working Instructions, Forms. 
• Audits: Contribute to the establishment and execution of the yearly audit plans including supervision of CAPA completion and effectiveness checks; Support auditor selection, contracting, and audit execution. 
• Clinical Trial oversight / Inspection readiness: Collaborate with clinical development teams to ensure robust trial oversight, vendor management, and inspection readiness.
• Regulatory Inspections: support preparation and hosting of regulatory authority inspections
• Clinical Risk Management: contribute / support clinical Risk Management and the development of risk mitigation strategies.
• Training & Knowledge Management: Develop and execute training plans, conduct onboarding training and refresher sessions, develop and maintain training documentation system
• Quality-related inquiries: organize and supervise QA mailbox, process inquiries within QA Team and ensure timely replies (either reply as Subject Matter Expert (SME) or contribute to elaboration of reply), participate in selected trial team meetings as SME
• QA filing and archiving system: ensure state-of-the-art QA filing and archiving systems, serving as an expert for Trial Master File (TMF) processes.