Digital Products Quality Engineering Lead (all genders)

Merck Life Science; Darmstadt; On-site; EUR 90,000 - 120,000; Full time

Job summary

Merck Life Science in Darmstadt seeks a Digital Products Quality Engineering Lead to shape the quality strategy for digital products in an Agile environment. You will lead a team of software quality engineers, ensuring compliance with GMP/GCP/21 CFR Part 11 and quality standards across life-science initiatives.

You will establish and improve QA processes, drive built-in quality and risk-based management, and partner with global cross-functional teams to accelerate safe, compliant go-to-market

Qualifications

• Bachelor’s or higher in Computer Science or related field.
• 10+ years in software development, digital transformation, QA or quality management.
• Experience leading teams and coaching.
• Strong knowledge of lifecycle, Agile, DevOps, Lean, and 21 CFR Part 11.
• Understanding of GMP, GCP, GLP, and ISO standards.
• Experience with change and incident management, audits and CAPA.
• Willing to travel globally.

Responsibilities

• Shape the quality strategy for digital products in Agile.
• Lead and develop a team of software quality engineers.
• Ensure products meet quality standards in regulated life-science environments.
• Establish and improve quality workflows, templates, and KPIs.
• Ensure traceability and inspection-ready artifacts.
• Influence engineering teams to strengthen quality mindset.

Skills

Team leadership

QA management

Agile development

DevOps

Test automation

Regulated environment

ISO standards

Communication

Education

BSc/BA in CS

Engineering degree

Life sciences degree

Biomedical Science

Tools

Microsoft Office

SharePoint

Project planning tools

Cloud platforms

Job description

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your role

As Digital Products Quality Engineering Lead, you will shape the quality strategy for digital products developed and maintained in an Agile environment. You will lead and develop a team of software quality engineers, ensuring that digital products meet the quality standards required by customers in regulated life-science environments. Working with global, cross-functional teams, you will champion built-in quality, shift-left practices, and continuous verification throughout the product lifecycle.

You will oversee end-to-end quality assurance and quality control activities, applying the four-eyes principle, managing escalations, and resolving issues with pace and clarity. You will establish and continuously improve software development processes, quality workflows, templates, and key quality indicators. By influencing engineering teams and strengthening their quality mindset, you will help turn complex challenges into practical actions that support faster go-to-market delivery. You will ensure that product engineering artifacts, traceability, testing evidence, and operational controls are inspection-ready and aligned with customer expectations and applicable regulations. Your expertise will help advance risk-based quality management, software test automation, DevOps, and continuous integration and delivery practices.

• You hold a bachelor's or higher degree in Computer Science, an Engineering discipline, Information or Operational Technology, Digital and Data Management, Information Science or Management, Biomedical Science, Life Sciences, or a related field.
• You bring at least 10 years of combined experience in software development or engineering, digital transformation, software quality assurance or control, and software quality management, ideally in a life-science or pharmaceutical environment.
• You have experience managing or supervising teams and building quality engineering capabilities through coaching, mentoring, and competency development.
• You have a strong command of the software product lifecycle, change management, Agile product development, DevOps, Lean, Plan-Do-Check-Act, software test automation, cloud platforms, and risk-based quality management systems; experience with Computer Software Assurance is an advantage.
• You understand GAMP 5 supplier-focused principles and relevant software-related ISO standards, as well as quality expectations in regulated environments, including GMP, GCP, GLP, and 21 CFR Part 11 compliance.
• You have a proven track record in software operational controls, including change and incident management, audit support, supplier quality, periodic reviews, deviations, and corrective and preventive actions.
• You are experienced in design reviews, verification activities, reviewing software engineering artifacts and testing evidence, managing defects, maintaining product traceability, and supporting audits or inspections.
• You communicate clearly in writing and verbally, are confident using tools such as Word, Excel, PowerPoint, SharePoint, and project-planning applications, and are willing to travel globally when required.

What we offer

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!