Quality Manager, Software and Regulated AI (m/f/d)

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 RoleYou 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 and govern the boundary for AI: where a language model may draft, where it may never execute, what evidence every automated step must leave behind, and when the system may run without a human in the loop.

• Own the certification framework for our analyses: reference case sets, conformance testing, the certificate register and its lifecycle, hosting of independent audits.

• Run internal audits and corrective actions, advise scientific teams on ICH M15 deliverables, and track AI regulation (EU AI Act, FDA and EMA guidance) into practical requirements.

What You Bring

• A software background: you have shipped code and can read a repository, a test suite and a CI pipeline without translation. This is the single most important requirement.

• Several years of quality management or computerized system validation in a regulated setting (CRO, pharma, biotech, medical software), with working knowledge of GAMP 5, ALCOA+, 21 CFR Part 11 and EU GMP Annex 11.

• Experience taking an organization through at least one certification audit (ISO 9001 or ISO/IEC 27001), from certification body selection to closure of findings.

• A working understanding of how language model agents behave in practice (tool calling, non-determinism, prompt injection) and the ability to explain to an auditor how a system with deterministic and non-deterministic parts is qualified.

• Fluent English, independent working in a remote cross-cultural team, and a pragmatic way with scientists. German and lead auditor or lead implementer training are a plus.

What's in store for youThe dynamic team behind ESQlabs unites people with different backgrounds, spanning disciplines like pharmaceutical sciences, physics, bioinformatics, mathematics, data science, and software engineering. Our trust in each other, our open-mindedness, and our constant quest for excellence and innovation unite us. We value flat hierarchies, where everyone can contribute ideas and expertise to develop the best product. W...