SW Tool Validation Lead

Stockholm, Remote. Posted a month ago

The role

You will lead the software tool validation and computer system validation function end to end. You will set the assurance approach, manage the CSV engineers, and perform hands-on testing to ensure systems are fit for intended use.

What you will do

Act as process owner for software tool validation.
Prioritise the tool estate by risk based on patient safety, product quality and data integrity impact.
Design and run assurance activities including mapping processes, identifying risks and testing systems.
Maintain the validated state of the estate through continuous validation activities.
Own how AI-enabled tools and systems are assured.
Own findings and issues across the estate from impact assessment to closure.
Lead and develop the CSV team.
Represent the function in audits and Notified Body assessments.

Required qualifications

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.
Deep, practical command of risk-based assurance: GAMP 5 (Second Edition), FDA Computer Software Assurance, ISO/TR 80002-2.
Experience assuring AI/ML-enabled systems in a regulated context.
Experience leading people or a function: line management, or sustained technical leadership of a validation team.
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.
Excellent written and verbal communication skills in English.

Nice to have

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.

About the company

Neko Health develops innovative medical technologies to make data-driven, preventative care accessible. The company uses proprietary technology and direct clinical care to deliver personalised insights.