As the Head of Quality Assurance at CatalYm, you will oversee all Quality Assurance activities in clinical development comprising all aspects of GxP governed processes with a main focus on GMP and GCP including Clinical Safety.
You will be responsible for establishing and maintaining a strong Quality Management System  and implementing quality oversight strategies ensuringe regulatory compliance and at the same time fostering a culture of quality and continuous improvement. 

Your tasks and responsibilities 

• Lead the QA department and take ownership of the quality management system (QMS) covering all GxP areas
• Exploring the needs for a transition to an electronic QMS solution and driving the decision making process
• Develop risk-based approaches to quality management in the GxP environment 
• Oversee the planning and execution of internal and external audits across all GxP areas
• Ensure inspection readiness across all departments governed by GMP and GCP
• Primary addressee for managing regulatory GxP inspections
• Align with C-level executives on quality initiatives required for inspection readiness
• Manage relationships with regulatory agencies and represent the company in quality-related matters