10+ years in computer system validation, software tool validation or software quality within medical device, pharmaceutical or another regulated industry.
BSc or MSc in Computer Science, Engineering, Information Systems or an equivalent technical discipline.
Pragmatic to the core. You can take a risk-based business decision and own it: what gets validated deeply, what gets a light touch, what gets deferred with a control in place, and what we consciously accept. You understand that assurance capacity is finite and that spending it evenly is the same as spending it badly.
Deep, practical command of risk-based assurance: GAMP 5 (Second Edition), FDA Computer Software Assurance, ISO/TR 80002-2.
Genuinely technical. You can get into a system, design and run meaningful tests against it, read its configuration and integrations, and form your own view of whether it holds up.
Experience assuring AI/ML-enabled systems in a regulated context, and a clear view of what changes when a system’s behaviour is not deterministic.
Experience leading people or a function: line management, or sustained technical leadership of a validation team.
A track record of finding real problems in systems and closing them: fast triage, honest impact assessment, clear containment, and the judgement to separate what actually matters from what merely looks non-conformant.
Working knowledge of EU MDR (2017/745), ISO 13485, FDA 21 CFR Part 820 and Part 11, and EU GMP Annex 11.
Experience across both configured/SaaS platforms and internally developed software, including scripts, automation and integrations.
Comfortable in fast-moving engineering environments, adapting assurance to continuous delivery rather than fighting it.
Excellent written and verbal communication skills in English.
Hands-on experience with Azure DevOps as a validation, traceability and defect management platform.
Experience with data integrity principles and practices (ALCOA+).
Experience with cloud-native and SaaS platforms in a regulated context.
Notified Body or FDA inspection experience.
Swedish or German language skills.

SW Tool Validation Lead

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