Senior Validation & Test Manager – Pharma / Life Sciences

Senior Validation & Test Manager – Pharma / Life Sciences

05 Nov 2025
Maine, Frankfurtammain 00000 Frankfurtammain USA

Senior Validation & Test Manager – Pharma / Life Sciences

We are seeking an experienced and driven Senior Validation & Test Manager to lead validation and testing across SAP implementations, upgrades and digital transformation initiatives. In this role, you will define and implement validation strategies, manage testing activities and ensure full compliance with GxP and global regulatory standards (FDA, EMA, etc.) throughout the project lifecycle. The position covers computer system validation (CSV), process validation / qualification activities, whilst ensuring complete traceability and regulatory adherence.Develop and implement validation and test strategies (incl. validation documentation) aligned with project goals, regulatory standards and quality policies.Ensure all validation deliverables adhere to good documentation practices (GDP) and are audit-ready in accordance with GAMP 5, ISO standards (ISO 27001, ISO 9001) and relevant FDA/EMA regulatory guidelines.Oversee validation and testing activities (e.g. end-to-end testing) across systems, processes and platforms including SAP, GxP systems and digital platforms.Apply risk-based approach to validation and testing scope definition and execution.Drive CAPA management, deviation investigations and root cause analysis for validation/test failures or compliance issues.Serve as a central point of contact for all validation and compliance-related activities within the project lifecycleTools & Technologies SAP (S/4HANA, SolMan, Cloud ALM) · Tricentis Tosca/Q-Test · Kneat · Veeva Vault · Jira/ALM · Signavio · BPMN 2.0 · other industry-recognized validation and testing tools

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