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Process architect quality management (qa/qc) (m/f/d)

Fresenius Medical Care
Inserat online seit: 20 März
Beschreibung

We are expanding our Business Transformation team and seeking a Process Architect Quality Management (QA/QC) (m/f/d). In this role, you will drive the design, testing, and deployment of SAP QM solutions (SAP S/4HANA) while defining and standardizing QA/QC processes across Pharma, BioPharma, and MedTech. You will work closely with global functions, production sites, and our central transformation team, collaborating with more than 40 manufacturing sites and Market Units to define requirements, design master data, and implement SAP templates. Acting as the link between operational teams and IT, you will ensure full alignment on process design and system functionality. Your responsibilities: Define, design, and document standardized QA and QC processes for Pharma, BioPharma, and MedTech archetypes. Lead configuration, testing, and deployment of SAP QM solutions on S/4HANA. Define and manage master data essential for global QA/QC process execution. Collaborate closely with global functions, manufacturing sites, and the central business transformation team to ensure consistent process application. Engage with more than 40 global manufacturing sites and Market Units to implement the SAP QM template. Serve as the key liaison between operational teams and IT, ensuring alignment of process design and system functionality. Conduct requirements engineering and create detailed software test definitions to ensure GxP‑compliant system performance. Ensure processes and SAP configurations meet regulatory requirements and industry best practices. Leverage SAP QM and related SAP solutions (e.g., SAP BRH) and integrate non-SAP quality systems (e.g., LIMS, QMS) where relevant. Provide global end‑user support and training during implementation; travel internationally as required. Your qualifications: Bachelor’s or Master’s degree in Life Sciences, Engineering, IT, or a related field. Extensive professional experience in pharmaceutical or MedTech industries as well as experience working in global business transformation programs across more than 40 sites. Proven expertise in SAP QM on S/4HANA within GxP‑regulated environments, and familiarity with SAP BRH and additional non-SAP quality tools (LIMS, QMS). Strong experience in designing and implementing QA/QC processes (level 3 to level 5) with a demonstrated ability to define and manage SAP master data for quality processes. Strong background in requirements engineering and software test definition. Strong communication and teamwork skills with the ability to collaborate effectively with global stakeholders. Exceptional analytical skills with an attention to detail and a proven ability to troubleshoot complex issues, developing innovative, compliant solutions. Proven project and leadership capabilities, paired with an ability to manage multiple priorities and drive projects to successful completion under tight deadlines, with a proactive, adaptable working style and willingness to travel internationally. Drive the future of our company — join futurefresenius and apply now through our online portal to make an impact!

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