Fresenius Kabi

Process Architect Quality Management (QA/QC) (m/f/d)

Fresenius Kabi  •  Federal Republic of Germany (Onsite)  •  15 days ago
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Job Description

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!

Fresenius Kabi

About Fresenius Kabi

As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With over 41,000 employees and present in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.

Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare.

Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.

User information & community guidelines: https://www.fresenius-kabi.com/social-media-terms-conditions

Imprint: www.fresenius-kabi.com/imprint

Industry
Chemicals & Materials
Company Size
10,000+ employees
Headquarters
Bad Homburg, DE
Year Founded
Unknown
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