Senior QA Manager: Validation & Quality Strategy

Hansa Biopharma AB; Lunds kommun; On-site; SEK 1,400,000 - 1,900,000; Full time

Job summary

Hansa Biopharma AB in Lund, Sweden, is seeking a Senior QA Manager Validation & Quality to lead validation strategy for drug substance and product development, scale-up, tech transfer and manufacturing activities.

You will drive QA processes, manage external CDMOs/CMOs, support regulatory inspections, and ensure compliant, robust manufacturing for development, clinical and commercial supply with a strong emphasis on risk-based compliance.

Qualifications

• Advanced degree required in chemical engineering, chemistry, pharmaceutical sciences or related field.
• 15+ years in biopharmaceutical QA, process development, manufacturing and validation.
• Experience with biotech/aseptic manufacturing and regulatory inspections (FDA/EMA/ICH).
• Strong communication and ability to influence across functions and levels.

Responsibilities

• Provide strategic and operational direction for validation within drug substance and drug product development, scale-up, tech transfer and manufacturing.
• Oversee development and implementation of QA/validation processes for compliant, robust manufacturing for development, clinical and commercial supply.
• Manage external partners (CDMOs/CMOs) aligning with quality expectations and program objectives.
• Support authority inspections and internal/external audits of suppliers and vendors.
• QA review and approval of validation documentation.
• Partner with CMC, Regulatory, Clinical, Supply Chain across functions.
• Establish relationships with internal and external stakeholders to ensure seamless QA execution.
• Drive continuous improvement of QMS and proactive quality improvements.

Skills

Communication skills

Interpersonal skills

Problem solving

Execution mindset

Education

PhD/MS in relevant field

Job description

Hansa Biopharma AB in Lund, Sweden, is seeking a Senior QA Manager Validation & Quality to lead validation strategy for drug substance and product development, scale-up, tech transfer and manufacturing activities.

You will drive QA processes, manage external CDMOs/CMOs, support regulatory inspections, and ensure compliant, robust manufacturing for development, clinical and commercial supply with a strong emphasis on risk-based compliance.