Senior QA Manager Validation & Quality
About this role
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
- 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.
- 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.
- Your Profile
- 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 thorou