Test & Validation Manager (Saas)

Test and Validation Manager Objective The Test and Validation Manager owns Agatha’s Test and Validation processes and makes sure every product release is delivered in a consistent, risk-based, traceable and compliant way. A key priority of the role is using AI to automate testing, validation and documentation. Working closely with Product, Engineering and Quality, you will make sure Test and Validation is built into how we develop and release products, in line with GxP requirements (GCP/GMP/Medical Device), 21 CFR Part 11, EU Annex 11, our internal procedures and GAMP 5. Responsibilities Process Ownership & Governance
• Own and continuously improve Test and Validation processes, methodologies, templates and acceptance criteria.
• Integrate these processes into product development, change management and release management, with clear roles, responsibilities and approval steps.
• Apply a risk-based approach, proportionate to product, patient, data integrity and regulatory risks.
• Ensure end-to-end traceability from requirements and risks to tests, deviations and release documentation.
• Define and track KPIs to measure process effectiveness.
• Support internal, customer and certification audits. Validation & Release Activities
• Plan and oversee validation for releases, patches, hot-fixes and periodic revalidation.
• Oversee key deliverables: requirements specifications, risk assessments, validation plans, test strategies and cases, traceability matrices, IQ/OQ documentation and validation summary reports.
• Make sure deviations and failed tests are documented, investigated and resolved before release.
• Provide a documented Test and Validation assessment for release readiness decisions.
• Maintain validation records throughout the product lifecycle. AI-driven Automation
• Lead the automation of testing, validation and documentation using AI, a main priority of the role.
• Extend automated test coverage (functional, regression, performance, patch) and use AI to generate and maintain test cases from requirements.
• Use AI to produce validation deliverables, while keeping documented human review and approval of every GxP record.
• Define how AI tools are qualified and controlled, in line with GAMP 5, data integrity requirements and Agatha’s Generative AI guidelines.
• Measure and report the impact of automation on release lead time, test coverage and validation effort. Cross-functional Coordination
• Clarify ownership and hand-offs between teams across the product lifecycle.
• Take part in change control and release governance.
• Escalate unresolved risks, process deviations or recurring quality issues.
• Act as the Test and Validation expert for Product and Engineering, and promote a quality and compliance mindset. Requirements
• 7+ years in Test, Computer System Validation and/or Quality roles in a regulated software or Life Sciences environment, including 2+ years as a manager.
• Proven track record designing or improving Test, Validation or Quality processes in a regulated software environment, ideally SaaS for Life Sciences customers.
• Strong knowledge of SDLC, testing methodologies, risk-based validation and GxP expectations for computerized systems (data integrity, electronic records and signatures).
• Hands-on experience with test automation, CI/CD tools (e.g. Jenkins) and AI tools applied to testing, validation or documentation.
• Experience with requirements management, traceability, change control, deviation and release management.
• Experience leading a test team, including external or offshore resources.
• Ability to turn regulatory requirements into pragmatic, scalable processes and to coordinate cross-functional teams.
• Fluent English; French and Japanese are a plus. Why joining Agatha? 🧬 Contribute to meaningful innovation in Life Sciences. 🌍 Join a friendly, international, and supportive team that loves what it does. 🚀 Play an active role in the growth of a European SaaS scale-up. 🤝 Enjoy flexibility, autonomy, and trust in the way you work.