Senior QA & Validation Leader - Biopharma Quality

Hansa Biopharma; Lunds kommun; On-site; SEK 1,400,000 - 2,100,000; Full time

Job summary

Hansa Biopharma in Lund, Sweden, seeks a Senior QA Manager Validation & Quality to lead validation strategies for drug substance and drug product across development, scale‑up, technology transfer and manufacturing.

You will drive quality systems, supplier qualification and risk‑based compliance, oversee CDMOs/CMOs, support inspections and audits, and collaborate with CMC, Regulatory, Clinical and Supply Chain to ensure robust, compliant operations for clinical and commercial programs.

Qualifications

• PhD or MS in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Pharmacist or related discipline.
• 15+ years of biopharmaceutical QA, process development, manufacturing and validation.
• Strong knowledge of biotech aseptic manufacturing incl testing.
• Deep understanding of FDA, EMA, ICH regulatory requirements.
• Experience managing external partners and CDMOs/CMOs.
• Experience with Authority inspections (FDA, EMA and other markets).
• Proven track record leading validation activities for drug substance and drug product development, scale‑up and manufacturing for clinical and commercial stages.
• Excellent communication and cross-functional collaboration.
• Hands-on, execution‑oriented mindset.

Responsibilities

• Provide strategic and operational direction for quality including validation within drug substance and drug product development, scale‑up, technology transfer, and manufacturing.
• Oversee development and implementation of quality and validation processes for compliant, robust and cost‑effective manufacturing.
• Manage external manufacturing partners (CDMOs/CMOs) to align with quality goals.
• Support authority inspections and internal and external audits of suppliers and vendors.
• QA review and approval of validation documentation.
• Partner cross‑functionally with CMC, Regulatory, Clinical, Supply Chain.
• Establish and maintain relationships with internal and external stakeholders for QA strategies.
• Drive continuous improvement of the Quality Management System (QMS).

Skills

Communication

Interpersonal skills

Problem solving

Execution mindset

Stakeholder management

Education

PhD or MS in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Pharmacist or related discipline

Job description

Hansa Biopharma in Lund, Sweden, seeks a Senior QA Manager Validation & Quality to lead validation strategies for drug substance and drug product across development, scale‑up, technology transfer and manufacturing.

You will drive quality systems, supplier qualification and risk‑based compliance, oversee CDMOs/CMOs, support inspections and audits, and collaborate with CMC, Regulatory, Clinical and Supply Chain to ensure robust, compliant operations for clinical and commercial programs.