Senior QA Validation & Quality Lead

Hansa Biopharma; Sweden; On-site; SEK 759,219 - 976,139; Full time

Job summary

Hansa Biopharma is looking for a Senior QA Manager Validation & Quality in Lund, Sweden. This role entails managing QA processes, validation documentation, and ensuring compliance for biopharmaceutical products. The ideal candidate will have a Ph.D. or M.S. in a related field and over 15 years of experience in the industry, particularly in QA development and regulatory compliance. The position is permanent and requires an on-site presence in the office.

Qualifications

• 15+ years of relevant biopharmaceutical industry experience.
• Strong experience managing external partners, CDMOs/CMOs.
• Experience of Authority inspections as presenter or coordinator.

Responsibilities

• Provide strategic and operational direction for quality expectation.
• Oversee implementation of quality and validation processes.
• Support authority inspections and audits of suppliers.

Skills

QA process development

Regulatory compliance (FDA, EMA, ICH)

Communication skills

Problem-solving skills

Education

Ph.D. or M.S. in Chemical Engineering or related discipline

Job description

Hansa Biopharma is looking for a Senior QA Manager Validation & Quality in Lund, Sweden. This role entails managing QA processes, validation documentation, and ensuring compliance for biopharmaceutical products. The ideal candidate will have a Ph.D. or M.S. in a related field and over 15 years of experience in the industry, particularly in QA development and regulatory compliance. The position is permanent and requires an on-site presence in the office.