Process Architect Quality Management (m/f/d)

100055 Fresenius Kabi Deutschland GmbH; Bad Homburg vor der Höhe; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A global healthcare company located in Bad Homburg is looking for a Process Architect in Quality Management. This role involves designing and deploying SAP quality management solutions while ensuring compliance with industry regulations. The ideal candidate will have substantial experience in the pharmaceutical or MedTech sectors and a strong background in SAP QM. This position offers an exciting opportunity to collaborate with global manufacturing sites and enhance process efficiencies.

Qualifikationen

• Extensive industry experience in pharmaceutical or MedTech sectors.
• Proven expertise in SAP QM, ideally on the S/4 HANA platform.
• Experience in designing and implementing Quality Management processes.
• Strong background in requirements engineering.
• Familiarity with SAP and non-SAP quality-related products.

Aufgaben

• Define and document standardized Quality Management processes.
• Collaborate with global functions to ensure consistent process application.
• Conduct requirements engineering and develop software test definitions.
• Provide training and support to end-users.

Kenntnisse

Requirements engineering

Software test definition

SAP QM module

Analytical skills

Communication skills

Ausbildung

Bachelor's or Master’s degree in Life Sciences, Engineering, Information Technology, or a related field

Tools

SAP S/4HANA

Batch Release Hub (SAP BRH)

LIMS

QMS

Jobbeschreibung

Process Architect Quality Management (m/f/d) page is loaded

Process Architect Quality Management (m/f/d)

Apply locations Bad Homburg (H28-30) time type Full time posted on Posted Yesterday job requisition id R-10007618

In the dynamic role of Process Architect Quality Management (m/f/d), you will be at the forefront of driving innovation and excellence within our global business transformation program. The position, based internationally, offers an unparalleled opportunity for professionals with substantial experience in the pharmaceutical or MedTech sectors.

As a key member of our team, you will be responsible for the design, testing, and deployment of cutting-edge SAP Quality Management solutions (SAP S/4HANA). You will lead the effort to define, standardize, and document Quality Management processes (L3-L5), ensuring compliance and efficiency across Pharma, BioPharma, and MedTech archetypes.

Your role will involve extensive collaboration with global functions, production sites, and our central transformation team. You will engage with over 40 global manufacturing sites and Market Units, playing a pivotal role in defining requirements, design master data and implementing SAP templates. Acting as a liaison between operational teams and IT, your expertise will ensure seamless alignment on process design and system functionality.

We seek a candidate with a strong background in requirements engineering and software test definition within GxP regulated environments. Extensive experience with SAP QM module (as user and/or as system integrator, responsible for solution design) and its integration with other SAP modules (e. g. PP, PP-PI, EWM) is a MUST. Your knowledge of additional SAP products such as Batch Release Hub (SAP BRH), as well as non-SAP products concerning quality processes (e. g. LIMS, QMS), would be a plus.

Your assignment

Process & System Design

• Define, design, and document standardized Quality Management processes (L3-L5) for Pharma, BioPharma, and MedTech archetypes.

• Lead the configuration, testing, and deployment of the SAP QM template on S/4 HANA in collaboration with IT resources, being able to question IT decisions.

• Define and manage SAP QM master data critical for the execution of quality processes together with local business.

Global Implementation & Collaboration

• Collaborate with global functions, production 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 template.

• Act as a liaison between operational teams and IT to ensure alignment on process design and system functionality.

Requirements Engineering & Testing

• Conduct requirements engineering and develop detailed software test definitions (PQs/UATs) to validate compliance with GxP regulations.

• Ensure quality processes and SAP configurations meet industry standards and regulatory requirements.

Leveraging SAP Solutions

• Utilize in-depth knowledge of SAP QM and related SAP products such as Batch Release Hub (SAP BRH) to enhance process efficiency.

• Stay updated with industry trends and emerging SAP and non-SAP functionalities to continuously improve quality management processes.

Travel & Stakeholder Engagement

• Travel internationally as required to support implementation and deployment at global production sites.

• Provide training and support to end-users, ensuring smooth adoption of new processes and systems.

Qualifications and Experience

Education

• Bachelor’s or Master’s degree in Life Sciences, Engineering, Information Technology, or a related field.

Professional Experience

• Extensive industry experience in the pharmaceutical or MedTech sectors.

• Proven expertise in SAP QM, ideally on the S/4 HANA platform, within GxP regulated environments.

• Deep experience in designing and implementing Quality Management processes (Level 3 to Level 5).

• Strong background in requirements engineering and software test definition.

• Demonstrated proficiency in defining and managing master data for SAP processes.

• Familiarity with SAP products such as Batch Release Hub (SAP BRH) and non-SAP quality-related products is beneficial.

• Experience in (global) business transformation projects involving more than 40 manufacturing sites.

Personal Skills and Capabilities

Communication & Interpersonal Skills

• Excellent verbal and written communication skills with the ability to engage and collaborate with global stakeholders.

• Strong interpersonal skills to foster teamwork across diverse cultures and business units.

Analytical & Problem-Solving

• Exceptional analytical skills with keen attention to detail.

• Proven ability to troubleshoot complex issues and develop innovative, compliant solutions.

Leadership & Project Management

• Strong project management and leadership capabilities with experience leading cross-functional teams.

• Ability to manage multiple priorities and drive projects to successful completion under tight deadlines.

Adaptability & Proactivity

• Proactive, adaptable, and resilient in a dynamic, transformational environment.

• Willingness to travel internationally to support global implementations.