Senior Validation
Vor 6 Tagen
Job DescriptionWe 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 toolsQualificationsBachelor’s/Master’s in Life Sciences, IT, Engineering or related field.5+ years in validation/testing within GxP-regulated environments.Strong understanding of CSV, GAMP 5, 21 CFR Part 11, Annex 11, ISO 9001/27001.Experience with SAP transformation / enhancement projects.Excellent communication and stakeholder engagement skills.Fluent English; German is a strong plus.Additional InformationAt Fusion, we aspire to be one of the world's leading life sciences consulting firms, setting industry benchmarks with innovative and pioneering solutions.At Fusion, we unite entrepreneurial minds from around the globe to develop and implement game-changing solutions that build lasting relationships with our clients.Hiring Philosophy: We value employees who push boundaries through innovation, navigating diverse client needs in ever-evolving environments, with a commitment to continuous learning both for themselves and their colleagues.Growth & Development: Go beyond, grow beyond, and maximize impact. Each employee shapes their own journey, and our mission is to ignite the spark of greatness while pushing the boundaries of what you are capable of. We cultivate an environment where every individual can thrive and flourish through meaningful connections, extended learning, motivation, and support to experiment with new and innovative approaches, including taking risks.Feedback Culture: We emphasize and promote continuous, real-time feedback across all levels. We see feedback as providing individuals with the information and tools they need to develop their strengths and overcome challenges. Feedback is a gift, and inspiring individuals is our competitive advantageShape you own journey - How far will you take yourself?
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