Test & Validation Manager

The Test and Validation Manager is responsible for defining, maintaining and continuously improving Agatha's Test and Validation processes to ensure that product releases are delivered through a consistent, risk-based, traceable and compliant approach. A strong focus of the role is the use of AI to automate testing, validation and documentation processes.

The position provides leadership and governance over the end-to-end Test and Validation lifecycle, from requirements and risk assessment through testing, validation, release readiness and periodic review.

The Test and Validation Manager works closely with Product, Engineering, Quality and other relevant stakeholders to ensure that Test and Validation activities are embedded into the product development and release processes and are performed in accordance with applicable GxP requirements, including GCP/GMP/Medical Device requirements, 21 CFR Part 11, EU Annex 11 where applicable, company procedures and recognized industry practices such as GAMP 5.

Job Responsibilities

Process Ownership & Governance

• Own, define, maintain and continuously improve the Test and Validation processes applicable to Agatha products, identifying process gaps, recurring issues and opportunities for improvement.
• Establish and maintain standardized Test and Validation methodologies, workflows, procedures, templates, acceptance criteria and supporting documentation.
• Ensure that Test and Validation activities are appropriately integrated into the product development lifecycle, change management and release management processes.
• Define clear roles, responsibilities, inputs, outputs, review steps and approval requirements across the Test and Validation lifecycle.
• Ensure consistent application of Test and Validation processes across products, releases and teams.
• Define and monitor appropriate KPIs and quality indicators to assess the effectiveness and efficiency of Test and Validation processes.
• Promote a risk-based approach to testing and validation, ensuring that the level of testing and validation is proportionate to product, patient, data integrity and regulatory risks.
• Ensure end-to-end traceability from requirements and identified risks through testing, deviations, resolution and release documentation.
• Ensure Test and Validation processes remain aligned with applicable regulatory requirements, internal Quality processes and recognized industry practices.
• Support internal, customer and certification audits by providing appropriate evidence and expertise.

Validation & Release Activities

• Plan, coordinate and oversee validation activities for general releases, patches, hot-fixes and periodic product revalidation.
• Ensure validation deliverables are planned, reviewed, approved and completed according to the applicable process and release timeline.
• Oversee the preparation and maintenance of requirements specifications, risk assessments, validation plans/protocols, traceability matrices, IQ/OQ documentation and validation summary reports.
• Define and oversee test strategies, test cases, scripts, acceptance criteria and execution.
• Ensure deviations, failed tests and validation findings are appropriately documented, investigated, resolved and traceable before release.
• Contribute to release readiness decisions by providing a documented assessment of Test and Validation completion and outstanding risks.
• Ensure appropriate maintenance of validation evidence and records throughout the product lifecycle.

AI-driven Test, Validation and Documentation Automation

• Drive the automation of testing, validation and documentation processes using AI, as one of the main priorities of the role.
• Extend automated test coverage (functional, regression, performance and patch testing) and use AI tools to generate and maintain test cases and scripts from requirements and specifications.
• Use AI to automate the production of validation deliverables, such as validation plans, traceability matrices, test evidence and validation summary reports, while keeping documented human review and approval of every GxP record.
• Define how AI tools are assessed, qualified and controlled within the Test and Validation process, in line with GAMP 5, data integrity requirements and Agatha's Generative AI usage guidelines.
• Measure the effect of automation on release lead time, test coverage and validation effort, and report progress to management.

Cross-functional Coordination

• Clarify ownership and hand-offs between teams and ensure that required Test and Validation inputs and outputs are available at each stage of the product lifecycle.
• Participate in change control and release governance activities where Test and Validation asses