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

In the dynamic role of Process Architect Quality Management - QA/QC (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 (S/4 HANA). You will lead the effort to define, standardize, and document QA and QC 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. Your knowledge of 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 QA and QC processes (L3-L5) for Pharma, BioPharma, and MedTech archetypes.

• Lead the configuration, testing, and deployment of the SAP QM template on S/4 HANA.

• Define and manage master data critical for the execution of quality processes.

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 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.

Your profile

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

• 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 QA and QC 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.

• 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.

• Exceptional analytical skills with a keen attention to detail.

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

• 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.

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

• Willingness to travel internationally to support global implementations.