Senior QA Manager Validation & Quality

SallyQ; Lunds kommun; On-site; SEK 70,000 - 90,000; Full time

Benefits offered by this job

Welcoming company culture

Opportunities for career development

Access to cutting-edge biopharmaceutical technology

Job summary

Hansa Biopharma is seeking an experienced Senior QA Manager Validation and Quality in Lund, Sweden. This pivotal role involves leading validation activities and supporting regulatory inspections, ensuring quality management across all phases of product development.

The ideal candidate will have over 10 years in the biopharmaceutical industry with a strong focus on quality assurance. Join a close-knit culture where you can significantly impact a fully integrated biopharmaceutical company.

Qualifications

• 10+ years of biopharmaceutical industry experience focusing on QA and validation.
• Strong knowledge of aseptic manufacturing processes.
• Experience managing external partners and coordinating authority inspections.

Responsibilities

• Drive and approve validation activities for QA.
• Support authority inspections and internal/external audits.
• Collaborate across functions including Regulatory and Clinical.

Skills

QA process development

Validation activities leading

Regulatory requirements knowledge

Strong communication skills

Education

Ph.D. or M.Sc. in Chemical Engineering, Chemistry, Pharmaceutical Sciences

Job description

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.

Requirements

• 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

• 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.

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, [phone] or [e-mail].