Process Architect Quality Management (m/f/d)

Fresenius SE & Co. KG aA; Bad Homburg vor der Höhe; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Fresenius SE & Co. KG aA is seeking a senior SAP QM lead to drive standardization and implementation of QM processes across Pharma, BioPharma, and MedTech.

You will design, configure, and validate SAP QM templates in SAP S/4HANA, collaborate with IT and global business teams, and manage master data to enable compliant quality workflows. The role requires extensive SAP QM/S4HANA experience, knowledge of BRH, BRH integrations with LIMS/QMS, and a track record in large-scale, international

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Cross-functional collaboration

Stakeholder management

Analytical problem solving

Global project experience

Ausbildung

University degree in Life Sciences, Engineering, IT, or related field

Tools

SAP QM

SAP S/4HANA

PP

PP-PI

EWM

LIMS

QMS

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.