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

ESQlabs GmbH; United States; Hybrid; USD 101,000 - 146,000; Full time

Benefits offered by this job

Flexible work hours

Home office policy

Remuneration package

Regular in-person team gatherings

Education budget

Ownership of projects and processes

Career perspective

Job summary

ESQlabs GmbH in Germany is seeking a Senior Quality Assurance professional to build and own the quality function for an auditable, AI-enabled platform. You will define the quality management system, validation approach, test plans and traceability from requirements to records, working with platform engineers and the CEO.

You will lead certifications (starting with ISO 9001), implement GAMP 5 and II compliance, and govern AI boundaries and evidence trails.

Qualifications

• Software background with code, repository, test suite, and CI pipeline familiarity.
• Several years of quality management or computerized system validation in a regulated setting (CRO, pharma, biotech, medical software) with GAMP 5, ALCOA+, 21 CFR Part 11 and EU GMP Annex 11.
• Experience leading at least one ISO 9001 or ISO/IEC 27001 certification audit.
• Understanding language model agents’ behavior and how to explain qualification to an auditor.

Responsibilities

• Own the quality management system and lead its certification (ISO 9001 first; information security and AI management standards follow).
• 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.

Skills

Software background

Quality management

Regulated setting

GAMP 5 knowledge

Certification audits

Lead auditor training

Fluent English

Job description

Location: Germany

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 Role

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.

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 you

The 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. We are passionate, always willing to broaden our horizons, and love our start-up culture.

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 us

We collaborate with global corporations in the pharma and chemical industry, as well as start-ups in the life-science technology sector and academic and non-profit research institutions. We define new standards in pharmacometrics and systems pharmacology and toxicology areas. Our software and model platforms help scientists understand mechanisms of diseases and chemical toxicity to optimize individualized treatment of patients and protect the health of the animal and human life.

ESQlabs has attracted international players as sponsors for the OSP Software development. In addition, funding through national and EU-wide research grants allows us to develop our core technologies continuously.

For more information about our culture, values and benefits visit our Unique career opportunities - esqLABS GmbH.

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.