About this role

Lead validation and testing activities across regulated systems and digital transformation initiatives.
Define, manage and optimize validation and testing frameworks for SAP and GxP systems.
Ensure full compliance with global regulatory standards (FDA, EMA, etc.).
Oversee validation and testing governance aligned with GxP, GAMP 5 and corporate quality standards.
Apply risk-based approach to validation and testing scope definition and execution.
Drive CAPA management, deviation investigations and root cause analysis for compliance issues.
Mentor validation and testing professionals and foster a culture of compliance.

Bachelor’s/Master’s in Life Sciences, IT, Engineering or related field.
7+ years in validation, testing or QA within GxP regulated industries.
Experience with SAP transformation / enhancement projects.
Deep understanding of GxP, CSV, GAMP 5, ISO standards, 21 CFR Part 11, Annex 11.
Strong leadership, stakeholder management and communication skills.
Fluent English; German is a strong plus.

Lead Validation & Test Manager – Pharma, Life Sciences

Key skills