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Hansa Biopharma develops innovative treatments that give patients with rare and serious immune-mediated conditions a chance to a better life. We are now looking for an experienced Senior QA Manager Validation and Quality, to help shape our quality work at one of the most exciting biotech companies in the Nordics. About the role The QA group at 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. Your 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 manufacturing partners (CDMOs/CMOs), ensuring alignment with quality expectations and program objectives throughout the product Life cycle. • Support authority inspection and internal Hansa/external audits of suppliers and vendors. • Partner cross-functionally with CMC, Regulatory, Clinical, Supply Chain • Establish and maintain strong relationships with internal and external stakeholders to ensure execution of QA strategies and operational tasks. • Drive continuous improvement initiatives such as -evaluate and update the Quality Management System (QMS), proactively identify areas for improvement. Who are you? We believe you are a Senior QA Professional with a broad background in Quality and Validation across both drug substance (DS) and drug product (DP) manufacturing. You are thorough, results-oriented and communicative, and motivated by progress and the sense of moving things forward. You collaborate easily with others while also being self-driven, comfortable taking initiative and making decisions when needed. At the same time, you know when to seek input and expertise from subject matter experts, both internally and externally. We are looking for someone with: • Advanced degree (Ph.D. or M.Sc .) in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Pharmacist or related discipline. • 10+ years of relevant biopharmaceutical industry experience, including significant roles in QA, process development, manufacturing and validation. • Proven track record of leading validation activities for drug substance and drug product development, scale-up, and manufacturing for clinical and commercial stages. •Strong knowledge and experience of biotech and aseptic manufacturing • Deep understanding of regulatory requirements (FDA, EMA, ICH) related to development, manufacturing and validation • Strong experience managing external partners and CDMOs/CMOs. • Strong experience of Authority inspections as presenter and/or coordinator (FDA, EMA and other markets) • Strong communication, and interpersonal skills with the ability to influence across functions and levels. • Strong problem-solving skills and a hands-on, execution-oriented mindset. What we offer Our culture and values Working at Hansa is more than a job for us, and our culture is characterised by pride — pride in what we do, in our co