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

• Own and continuously improve ESQlabs’ QMS, including policies, SOPs, work instructions, templates, and document control, and extend it to automated and agent-executed workflows.

• Own computerized system validation for our platform, using a risk-based approach in line with GAMP 5 Second Edition and Computer Software Assurance (CSA).

• Own the certification framework for our automated workflows, including reference cases, conformance testing, the certificate register, and independent audits.

• Define the governance of AI autonomy and human oversight: what agents may do, where human review is mandatory, and what evidence every agent action must leave behind.

• Translate data integrity principles (ALCOA+), 21 CFR Part 11, and EU GMP Annex 11 into concrete technical controls together with the Principal Platform Engineer.

• Run internal audits, including audits of agentic workflows in practice, drive CAPA to closure, and host external audits and client due diligence requests.

• Lead the ISO 9001 certification, coordinate ISO/IEC 27001 with the Principal Platform Engineer, and prepare ISO/IEC 42001 certification as part of one integrated system.

• Advise scientific teams on the quality of deliverables such as modeling reports and model qualification documentation, including alignment with ICH M15.

• Track the regulatory landscape for AI in regulated workflows (for example the EU AI Act, FDA and EMA guidance, and GAMP guidance on AI) and translate it into practical internal requirements.

• Deliver quality training, monitor quality metrics and non-conformances, and report on QMS performance to leadership.

What You Bring

• A degree in computer science, software engineering, informatics, life sciences, pharmacy, engineering, or related field.

• A genuine software background. You have written and shipped code, and you are comfortable with version control, containers, dependency management, automated testing, and CI/CD pipelines. This is the single most important requirement for this role.

• Several years of hands-on experience in quality management or computerized system validation within a CRO, pharmaceutical, biotech, medical software, or other regulated environment.

• Deep working knowledge of GAMP 5 (ideally including the Second Edition and the CSA shift), ALCOA+ data integrity principles, 21 CFR Part 11, and EU GMP Annex 11.

• Practical experience validating computerized systems, ideally cloud-hosted or multi-tenant systems, and ideally including supplier and vendor assessments.

• A working understanding of how large language models and agentic systems actually behave: tool calling, orchestration, non-determinism, evaluation, and the specific risks that come with them such as prompt injection through untrusted inputs.

• The ability to reason clearly about qualifying a system that contains both deterministic and non-deterministic components, and to explain that reasoning to an auditor.

• Experience developing and maintaining SOPs, managing document control, and running internal audits and CAPA processes.

• Experience taking an organization through at least one certification audit (ISO 9001 or ISO/IEC 27001), including certification body selection, audit hosting and CAPA closure.

• Lead implementer or lead auditor training in ISO 9001, ISO/IEC 27001 or ISO/IEC 42001 is a plus.

• A structured, detail-oriented way of working, combined with strong written and verbal communication skills.

• Fluency in English (written and spoken). German is a plus.

• The ability to work independently in a fully remote, cross-cultural team, and to build trusted working relationships with scientific and technical colleagues.

• A collaborative, pragmatic mindset, comfortable adapting general quality principles to the realities of a scientific consultancy.