Senior Software Validation & CSV Lead

Neko Health AB; Stockholms kommun; On-site; SEK 1,000,000 - 1,400,000; Full time

Job summary

Neko Health AB is seeking a SW Tool Validation Lead to direct software tool validation and CSV across our platforms. You will set the assurance approach, lead a CSV team, and test systems hands‑on to build a strong audit-ready evidence base.

This role combines hands‑on testing with strategic leadership, ensuring AI-enabled tools meet patient safety and data integrity standards while collaborating with engineering, quality, clinical operations and regulatory affairs.

Qualifications

• 10+ years in computer system validation, software tool validation or software quality within medical device, pharmaceutical or another regulated industry.
• GAMP 5 (Second Edition), FDA Computer Software Assurance knowledge.
• Experience assuring AI/ML-enabled systems in a regulated context.
• Experience leading people or a function, with line management or technical leadership.

Responsibilities

• Act as process owner for software tool validation, setting the assurance approach and the standards the function works to.
• Prioritise the tool estate by risk, allocating assurance effort according to patient safety, product quality and data integrity impact.
• Design and run assurance activities yourself: map the process, identify the risks and requirements, test the system, and form your own evidence-based view before you approve anything.
• Maintain the validated state of the estate as it changes, integrates, migrates and retires, running validation as a continuous activity rather than a periodic campaign.
• Own how we assure AI-enabled tools and systems, where non‑determinism, model updates and opaque supplier behaviour break the assumptions conventional validation rests on.
• Own findings and issues across the estate, from honest impact assessment through containment to closure.
• Lead and develop the CSV team, with clear system ownership and engineers who make and defend their own risk calls.
• Represent the function in audits and Notified Body assessments, presenting and defending the assurance case for our systems.

Skills

English communication

Leadership

Risk-based decision making

Strategic thinking

Education

BSc or MSc in Computer Science, Engineering, Information Systems

Tools

Azure DevOps

Job description

Neko Health AB is seeking a SW Tool Validation Lead to direct software tool validation and CSV across our platforms. You will set the assurance approach, lead a CSV team, and test systems hands‑on to build a strong audit-ready evidence base.

This role combines hands‑on testing with strategic leadership, ensuring AI-enabled tools meet patient safety and data integrity standards while collaborating with engineering, quality, clinical operations and regulatory affairs.