As the Head of Quality Assurance at CatalYm, you will lead our quality efforts in clinical development, with a focus on phase 1-2 clinical trials. This role will oversee Quality Assurance across all GxP areas, with particular emphasis on GCP and GVP. The successful candidate will be responsible for developing and implementing quality strategies that ensure compliance and drive continuous improvement and at the same time fostering a culture of quality. In this role you will need to have a strong hands-on mentality and proactively managing our QA responsibilities together with a small team of currently one QA Manager. 
 
Your tasks and responsibilities
 

• Lead the further implementation activities towards a comprehensive quality management system (QMS) covering all GxP areas, including the transition to an electronic QMS solution
• Drive and lead inspection activities according to global regulatory requirements (e.g. FDA, EMA, etc.)
• Develop risk-based approaches to quality management in clinical development
• Collaborate with C-level to align quality initiatives with business objectives
• Provide strategic direction for Quality Assurance in clinical trials and pharmacovigilance activities
• Oversee the planning and execution of internal and external audits across all GxP areas
• Manage relationships with regulatory agencies and represent the company in quality-related matters
• Drive the initiatives of quality technology solutions to enhance efficiency and compliance