Senior QA Manager Validation & Quality
SallyQ AB · Lund · Tills vidare
Hansa Biopharma, recruiting through SallyQ AB, is seeking a **Senior QA Manager Validation & Quality** based at its office in Lund. Joining a QA team of six colleagues, the postholder provides strategic and operational direction for validation and quality management across development, clinical, and commercial manufacturing. Core responsibilities include QA review and approval of process, cleaning, and analytical method validation documentation, overseeing supplier quality by qualifying CDMO and CMO partners throughout the product lifecycle, and supporting authority inspections as well as internal and external audits. The role also involves collaborating cross-functionally with CMC, Regulatory, Clinical, and Supply Chain teams, alongside driving continuous improvements to the Quality Management System. Applicants must hold an **advanced degree (Ph.D. or M.Sc.)** in chemical engineering, chemistry, pharmaceutical sciences, or a related discipline. The role requires at least **10 years of biopharmaceutical industry experience** focused on QA, process development, and validation, including a track record of leading drug substance and drug product validation across clinical and commercial stages. Essential qualifications also comprise deep understanding of FDA, EMA, and ICH regulatory requirements, expertise in aseptic manufacturing and biotechnology processes, experience managing external CDMO/CMO partners, background presenting or coordinating during authority inspections, and strong cross-functional communication skills.
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
You will be a key player in a QA team of six dedicated colleagues, all based at our office in Lund. As Senior QA Manager, you will drive and approve validation activities - spanning process, cleaning and analytical method validation - with a clear quality perspective. You will act as subject matter expert supporting cross-functional teams, external partner management and regulatory authority inspections.
This is the right role for you if you thrive with both strategic ownership and operational presence - where one day you are reviewing validation documentation and the next you are in dialogue with a CDMO or preparing a team for an authority inspection.
Your responsibilities:
- Provide strategic and operational direction for quality management and validation across development, clinical and commercial manufacturing
- QA review and approval of validation documentation
- Supplier quality management: guide and qualify external manufacturing partners (CDMOs/CMOs) throughout the product lifecycle
- Support authority inspections and internal/external audits of suppliers and vendors
- Cross-functional collaboration with CMC, Regulatory, Clinical and Supply Chain
- Drive continuous improvement of the Quality Management System (QMS) and proactively identify areas for development
Who are you?
We believe you are a seasoned QA professional with broad experience across both drug substance (DS) and drug product (DP) manufacturing. You are thorough and results-oriented, but also a natural collaborator who knows when to take the lead and when to seek input from others.
We are looking for someone with:
- Advanced degree (Ph.D. or M.Sc.) in Chemical Engineering, Chemistry, Pharmaceutical Sciences or a related discipline
- 10+ years of biopharmaceutical industry experience with a focus on QA, process development and validation
- Proven track record of leading validation activities for DS and DP through clinical and commercial stages
- Strong knowledge of aseptic manufacturing and biotechnology processes
- Deep understanding of regulatory requirements (FDA, EMA, ICH) related to manufacturing and validation
- Experience managing external partners and CDMOs/CMOs
- Experience of authority inspections (FDA, EMA) as presenter and/or coordinator
- Strong communication skills and the ability to influence across functions and organisational levels
What we offer
At Hansa, you will not just have a job - you will have a role where your work directly contributes to changing lives for patients with acute and complex immune disorders.
- A close-knit, welcoming culture in a mid-sized company where you can see how your contribution makes a difference
- The opportunity to help build a fully integrated biopharmaceutical company with global reach
- Talented, driven colleagues with an open and entrepreneurial mindset
- A strong pipeline built on Hansa’s proprietary IgG-cleaving enzyme technology platform
- Office in Lund, at the heart of a vibrant Life Science ecosystem
Our values
At Hansa, we are guided by our core values: Accountability, Courage, Integrity and Pioneering. We believe in the power of diversity and are committed to building an inclusive workplace where every perspective is valued.
Appealing?
Send in an application as soon as possible. In this recruitment, Hansa Biopharma is collaborating with SallyQ. For questions, please contact Ellinor Crafoord, Senior Recruitment Consultant, +46793554257 or ellinor.crafoord@sallyq.se.