Senior QA Manager Validation & Quality

Job description

The role Hansa Biopharma is growing and is now seeking a Senior QA Manager Validation and Quality. The QA group consists today of six colleagues who all work at the Lund office. Hansa is a growing, biotech company with a strong R&D pipeline as well as a commercial product within rare disease. As Senior QA Manager, you will contribute with your deep expertise in validations (e.g of process, cleaning and analytical method) from a quality perspective as well as with your extensive knowledge in quality systems, supplier qualification, and risk-based compliance. You will act as a subject matter authority for validation and QA processes, supporting cross-functional teams and driving quality excellence across internal operations and external suppliers. Responsibilities: Provide strategic and operational direction for Quality Management, and support validation, process development development and external manufacturing activities. Oversee development and implementation of quality and validation processes to ensure compliant processes for development, clinical and commercial supply. QA review and approval of validation documentation. Quality Supplier Management including guiding external ma...