SW Tool Validation Lead

Location: Stockholm, Sweden; hybrid

Company

hirify.global develops non-invasive medical technologies and preventative care solutions that deliver personalised, data-driven health insights.

What you will do

• Own the software tool validation and computer system validation function, including its assurance approach, standards, and processes.
• Prioritise systems by patient safety, product quality, and data integrity risk.
• Design and perform process mapping, risk assessment, requirements analysis, system testing, and evidence-based approvals.
• Maintain the validated state of configured platforms, internally developed systems, integrations, migrations, and retired systems.
• Define assurance practices for AI-enabled systems and manage findings from impact assessment through containment and closure.
• Lead and develop the CSV engineering team and represent the function in audits and Notified Body assessments.

Requirements

• 10+ years of experience in computer system validation, software tool validation, or software quality within a regulated industry.
• BSc or MSc in Computer Science, Engineering, Information Systems, or an equivalent technical discipline.
• Deep practical knowledge of GAMP 5 Second Edition, FDA Computer Software Assurance, and ISO/TR 80002-2.
• Experience validating AI/ML-enabled systems, configured and SaaS platforms, internally developed software, scripts, automation, and integrations.
• Experience leading people or a validation function, with strong technical testing, issue triage, impact assessment, and remediation skills.
• Working knowledge of EU MDR 2017/745, ISO 13485, FDA 21 CFR Parts 820 and 11, and EU GMP Annex 11; excellent written and verbal English.

Nice to have

• Hands-on experience with Azure DevOps for validation, traceability, and defect management.
• Experience with ALCOA+ data integrity principles, cloud-native and SaaS platforms in regulated environments.
• Notified Body or FDA inspection experience.
• Swedish or German language skills.

Culture & Benefits

• Hands-on leadership role combining strategic direction, team coaching, and direct system testing.
• Risk-based validation aligned with GAMP 5 Second Edition and FDA Computer Software Assurance guidance.
• Opportunity to support the scaling of systems, integrations, and markets while improving early detection of real problems.
• Fast-moving engineering environment focused on continuous delivery rather than periodic validation campaigns.