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

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 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.

• 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.

You will also benefit from:

• Flexible work hours and a home office policy that focuses on people and not on numbers
• An attractive remuneration package
• Regular in-person team gatherings at locations across Europe.
• The opportunity to define what quality assurance means for agentic scientific software, at a point when the standard is still being set.
• A dedicated budget for education programs and conferences you can attend
• A working environment in which your contribution will make a difference, and that allows you to take ownership of projects and processes
• Responsibility, autonomy, participation, and career perspective

About the Role

ESQlabs is an equal-opportunity employer. We welcome applications from all qualified candidates regardless of background, and value the diversity of perspectives this brings to our team.