Process Architect Quality Management (m/f/d)

Fresenius; Bad Homburg vor der Höhe; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Fresenius SE & Co. KGaA in Germany seeks an experienced SAP QM specialist to shape and implement quality management processes across Pharma, Biopharma, and MedTech.

You will standardize templates, drive S/4HANA configurations, and collaborate with IT and business stakeholders worldwide. The role leads global rollouts at more than 40 manufacturing sites, ensuring GxP compliance, mastering data, and coordinating validation efforts (PQ/UAT).

Qualifikationen

• University degree in Life Sciences, Engineering, IT or related field.
• Extensive pharma/biopharma/MedTech experience with GxP exposure.
• Hands-on SAP QM in SAP S/4HANA; design/integration with PP, PP-PI, EWM.
• Proven ability to design, implement, and standardize QM processes (L3-L5).
• Experience with BRH and non-SAP systems such as LIMS/QMS desirable.
• Strong communication and cross-cultural collaboration skills; travel-ready.

Aufgaben

• Define, standardize, and document Quality Management processes across Pharma, BioPharma and MedTech archetypes.
• Lead design, configuration, testing, and deployment of the SAP QM template on SAP S/4HANA with IT teams.
• Define and manage SAP QM master data with local business stakeholders.
• Collaborate with global functions, manufacturing sites, and central transformation team for compliant implementation.
• Drive rollout across 40+ global manufacturing sites and Market Units.
• Act as the IT–business interface for requirements, design, and validation (PQ/UAT).
• Ensure regulatory and industry standards alignment for QM solutions.
• Support integration with non-SAP systems (LIMS/QMS) and explore emerging tech.

Kenntnisse

SAP QM expertise

S/4HANA experience

GxP compliance

Requirements engineering

Stakeholder management

Cross-functional collaboration

Ausbildung

University degree in Life Sciences, Engineering, Information Technology, or a related field

Tools

SAP QM

SAP S/4HANA

BRH (Batch Release Hub)

LIMS and QMS integration

Jobbeschreibung

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.

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