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FRFresenius Kabi Deutschland GmbH

Process Architect Quality Management (QA/QC)(m/w/x)

Bad Homburg vor der Höhe
Full-timeOn-siteSenior

Designing and deploying SAP QM solutions on S/4HANA for QA/QC processes across 40+ global Pharma/MedTech sites. Expertise in SAP QM on S/4HANA within GxP-regulated environments required. Global collaboration across 40+ sites in a specialized healthcare technology company.

Requirements

  • Bachelor’s or Master’s degree in Life Sciences, Engineering, IT, or related field
  • Extensive professional experience in pharmaceutical or MedTech industries
  • Experience in global business transformation programs (40+ sites)
  • Proven expertise in SAP QM on S/4HANA (GxP-regulated environments)
  • Familiarity with SAP BRH
  • Familiarity with non-SAP quality tools (LIMS, QMS)
  • Strong experience in designing/implementing QA/QC processes (level 3-5)
  • Ability to define/manage SAP master data for quality processes
  • Strong background in requirements engineering
  • Strong background in software test definition
  • Strong communication skills
  • Strong teamwork skills
  • Ability to collaborate with global stakeholders
  • Exceptional analytical skills
  • Attention to detail
  • Ability to troubleshoot complex issues
  • Ability to develop innovative, compliant solutions
  • Proven project capabilities
  • Proven leadership capabilities
  • Ability to manage multiple priorities
  • Ability to drive projects to completion under tight deadlines
  • Proactive, adaptable working style
  • Willingness to travel internationally

Tasks

  • Define, design, and document QA/QC processes for Pharma, BioPharma, and MedTech.
  • Lead configuration, testing, and deployment of SAP QM solutions on S/4HANA.
  • Define and manage master data for global QA/QC processes.
  • Collaborate with global teams for consistent process application.
  • Engage with over 40 global sites to implement SAP QM template.
  • Liaise between operational teams and IT for process and system alignment.
  • Conduct requirements engineering for GxP-compliant systems.
  • Create detailed software test definitions for GxP-compliant systems.
  • Ensure processes and SAP configurations meet regulatory requirements and best practices.
  • Leverage SAP QM and related SAP solutions.
  • Integrate non-SAP quality systems like LIMS and QMS.
  • Provide global end-user support and training during implementation.
  • Travel internationally as required.

Work Experience

  • approx. 4 - 6 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • SAP QM
  • S/4HANA
  • GxP
  • SAP BRH
  • LIMS
  • QMS
  • SAP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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