Test and 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.

Objective

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.

Job Responsibilities

Process Ownership & Governance

• 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.

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 assessment is required.
• Escalate process deviations, unresolved validation risks or recurring quality issues to the appropriate stakeholders.
• Provide Test and Validation expertise to Product and Engineering teams and contribute to the development of a quality and compliance mindset throughout the organization.

Requirements

• At least 7 years of relevant experience in Test, Computer System Validation and/or Quality roles within a regulated software or Life Sciences environment.
• At leat 2 years as manager
• Demonstrated experience in designing, implementing or improving Test, Validation or Quality processes in a regulated software environment.
• Strong understanding of software development lifecycle (SDLC), software testing methodologies and risk-based validation approaches.
• Hands-on experience with test automation frameworks and CI/CD tooling (for example Jenkins), and practical experience using AI tools to automate testing, validation or documentation activities.
• Experience with requirements management, traceability, change control, deviation management and release management.
• Experience working in a SaaS environment supporting regulated Life Sciences customers.
• Strong understanding of GxP expectations applicable to computerized systems, including data integrity and electronic records/electronic signatures requirements.
• Ability to translate regulatory and quality requirements into pragmatic and scalable operational processes.
• Demonstrated ability to coordinate cross-functional activities involving Product, Engineering and Quality teams.
• Experience leading and developing a test team, including external or offshore test resources.
• Strong process ownership, analytical and continuous improvement mindset.
• Fluent in English
• French and Japan is plus