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.
This role provides strategic and hands-on oversight across internal operations and external partners (CMOs, CDMOs, and CROs), ensuring product quality, patient safety, and regulatory compliance throughout the product lifecycle 

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 
• Develop and maintain the company’s Quality Strategy aligned with corporate goals and regulatory expectations (ICH Q10, EU GMP, 21 CFR 210/211, 600, 820)
• 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
• Serve as a member of the Development Leadership Team or Product Lifecycle Team, providing quality input to CMC, regulatory, and clinical operations decisions
• Establish a phase-appropriate QMS suitable for a small biotech environment with outsourced manufacturing
• Build a quality culture emphasizing transparency, continuous improvement, and accountability