Process Architect Quality Management (m/f/d)
Fresenius Kabi · Bad Homburg vor der Höhe
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!