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

ESQlabs

26d • Remote

About The Position

ESQlabs is seeking a Quality Manager to build the quality function for a new platform that will be certified, not just validated. This role involves owning 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. The Quality Manager will define the standards for the platform engineers and report to the CEO. The role starts with an interim consultant and a build team that has written its first requirements and glossary. The company 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, combining 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). Their mission is to empower life sciences by 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, quality and traceability are central to their value proposition. They are building an automated, AI agent-orchestrated platform for regulated modeling workflows that needs to be qualifiable from the first step.

Requirements

• A software background: you have shipped code and can read a repository, a test suite and a CI pipeline without translation.
• 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.

Nice To Haves

• German and lead auditor or lead implementer training are a plus.

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed