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Process Architect Quality Management (m/f/d)

100055 Fresenius Kabi Deutschland GmbH · Bad Homburg, Germany

ArchitectureSenior LevelQuick applyfull-timeabout 9 hours ago

About The Role

In this international key role, you will drive innovation and operational excellence as part of our global business transformation program. You will play a pivotal role in designing, standardizing, and implementing Quality Management processes and SAP S/4HANA solutions across our Pharma, BioPharma, and MedTech organizations, working closely with business and IT stakeholders worldwide.

Your responsibilities

  • Define, standardize, and document Quality Management processes (L3-L5) across Pharma, BioPharma, and MedTech archetypes.
  • Lead the design, configuration, testing, and deployment of the SAP QM template on SAP S/4HANA in close collaboration with IT teams, providing expert guidance and constructively challenging solution decisions where required.
  • Define and manage SAP QM master data critical for the execution of quality processes in partnership with local business stakeholders.
  • Collaborate with global functions, manufacturing sites, and the central transformation team to ensure consistent process implementation, compliance, and adoption.
  • Drive the rollout and implementation of SAP templates across more than 40 global manufacturing sites and Market Units.
  • Act as the key interface between operational teams and IT, ensuring alignment of business requirements, process design, and system functionality.
  • Conduct requirements engineering and develop detailed software test definitions and validation activities (PQs/UATs) to ensure GxP-compliant solutions.
  • Ensure quality processes, SAP configurations, and system designs meet applicable regulatory requirements and industry standards.
  • Leverage SAP QM expertise and related solutions such as SAP Batch Release Hub (BRH), while supporting integration with quality-related non-SAP systems (e.g., LIMS, QMS) and continuously evaluating emerging technologies and industry best practices.
  • Support global implementations through international travel, end-user training, change management, and ongoing deployment support.

Your qualifications

  • University degree in Life Sciences, Engineering, Information Technology, or a related field.
  • Extensive experience in the pharmaceutical, biopharmaceutical, or MedTech industry, including work within GxP-regulated environments.
  • Extensive hands-on experience with SAP QM, ideally in SAP S/4HANA environments, as a business user and/or system integrator with responsibility for solution design, including integration with modules such as PP, PP-PI, and EWM.
  • Proven expertise in designing, implementing, and standardizing Quality Management processes (L3-L5), as well as defining and managing SAP master data.
  • Strong background in requirements engineering, software testing, validation, and compliance-related activities.
  • Experience with SAP Batch Release Hub (BRH) and quality-related non-SAP applications such as LIMS and QMS is highly desirable.
  • Demonstrated success in large-scale global business transformation programs, ideally involving more than 40 manufacturing sites, including experience leading cross-functional and international project teams.
  • Excellent communication, stakeholder management, interpersonal, analytical, and problem-solving skills, with the ability to develop innovative, compliant solutions, manage multiple priorities in a fast-paced transformation environment, and collaborate effectively across cultures.

Drive the future of our company — join #futurefresenius and apply now through our online portal to make an impact!

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