ESQlabs GmbH
ESQlabs is an innovative, internationally active Contract Research Organization (CRO) and a global leader in the development and application of the Open Systems Pharmacology (OSP) Suite. We combine mechanistic modeling, Physiologically Based Pharmacokinetics (PBPK) and Quantitative Systems Pharmacology (QSP), with software and training to support Model-Informed Drug Development (MIDD) and Next-Generation Risk Assessment (NGRA) for pharmaceutical, chemical, and academic partners worldwide. Our mission is to empower life sciences: helping scientists understand mechanisms of disease and chemical toxicity to optimize individualized, safer, and more efficient treatment and testing strategies.
As a scientific consultancy serving regulated industries, the quality and traceability of our work are central to our value proposition. We are now extending that discipline from documents and reports to software: we are building an automated, AI agent-orchestrated platform for regulated modeling workflows, and we need it to be qualifiable from the first step, rather than validated retrospectively.
About the Role
You build the quality function for a platform that will be certified, not just validated. You own the quality management system, the validation approach for an agent-orchestrated scientific system, the test plan and test reports, and the traceability from requirement to design to test to record. You define the standards; the platform engineers implement them. You report to the CEO, and you start with an interim consultant already in place and a build team that has written its first requirements and glossary.
You Will
Own the quality management system and lead its certification (ISO 9001 first; information security and AI management standards follow), designed as one integrated system.
Own validation of the platform under GAMP 5 second edition and computer software assurance: requirements with stable identifiers, test plan, test reports, traceability, supplier assessment.
Define an…
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