Remote job
Quality Manager, Software and Regulated AI (m/f/d)
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About this role
Role overview Build and lead the quality function for a scientific software platform that uses AI agents to support regulated modeling workflows. You will establish its quality management system, define how the platform is validated and certified, and turn regulatory expectations into practical standards for engineers and scientific teams.
Responsibilities - Lead an integrated quality management system, beginning with ISO 9001 certification and preparing for later information security and AI management standards. - Set the validation approach under GAMP 5 and computer software assurance, covering requirements, test plans and reports, traceability, and supplier assessment. - Define controls for AI use, including permitted actions, required evidence, and when human oversight is necessary. - Develop and maintain certification for analyses, including reference cases, conformance testing, certificate records, and independent audits. - Conduct internal audits, manage corrective actions, advise scientific teams on ICH M15 deliverables, and translate AI regulation and guidance into requirements.
Requirements - Software
experience: able to work with shipped code, repositories, test suites, and CI pipelines. - Several years in quality management or computerized system validation in a regulated setting, with knowledge of GAMP 5, ALCOA+, 21 CFR Part 11, and EU GMP Annex 11. - Experience guiding an organization through an ISO 9001 or ISO/IEC 27001 certification audit, including resolving findings. - Practical understanding of language model agents, including tool use, non-determinism, and prompt injection, and ability to explain qualification of mixed deterministic and non-deterministic systems. - Fluent English, ability to work independently with a remote cross-cultural team, and a pragmatic approach to working with scientists.
Nice to have - German language skills. - Lead auditor or lead implementer training.
Benefits and work setup Flexible hours, a home office policy, regular in-person gatherings across Europe, and a dedicated budget for education and conferences. The role offers autonomy and the opportunity to shape quality practices for agent-driven scientific software.