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Open nowPosted 105 days ago

Senior QA Manager Validation & Quality

Arbetsförmedlingen (Platsbanken)39,552 open roles

Where
Lund, Skåne län, Sweden
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Your applicationOpen nowSenior QA Manager Validation & QualityArbetsförmedlingen (Platsbanken) · Lund, Skåne län, Sweden

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This job: posted 105 days ago

The posting

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 [email protected].

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