Lead Validation

vor 3 Wochen

Frankfurt am Main, Deutschland Fusion Consulting Vollzeit

Company Description Swiss Delivery Excellence: Transforming Life Science Consulting Worldwide.
Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health.
Focused on S4HANA, Data & Cloud, and innovative technologies, Fusion Consulting brings unparalleled expertise and commitment to excellence to every project we undertake.
With unwavering support and an entrepreneurial spirit, our global teamwork transcends boundaries and turns shared visions into reality.
We are seeking a highly skilled and motivated Lead Validation & Test Manager to lead validation and testing activities across a portfolio of regulated systems and digital transformation initiatives. In this role, you will be responsible for defining, managing and optimizing validation and testing frameworks for SAP and GxP systems, ensuring full compliance with global regulatory standards (FDA, EMA, etc.). This position requires a strong balance of strategic leadership, technical expertise and operational oversight across global programs. It spans computer system validation (CSV), process validation and qualification activities, ensuring full traceability and adherence to GxP and global regulatory standards.
Oversee and coordinate validation and testing (e.g. end-to-end testing) across SAP, GxP and digital systems, whilst ensuring consistency, quality and compliance throughout.
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 lifecycle.
Mentor validation and testing professionals, fostering a culture of quality, compliance, and best practice adoption.
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
Bachelor's/Master's in Life Sciences, IT, Engineering or related field.
~Experience with SAP transformation / enhancement projects.
~ Fluent English; German is a strong plus.

At 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.
We emphasize and promote continuous, real-time feedback across all levels.

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