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Bad Homburg, DEUPermanentFull-time

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

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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.

Your benefits

FlexBenefits

FlexBenefits

Deutschlandticket, job bike or would you prefer an increase in the childcare allowance? With the Fresenius FlexBenefits program, you can choose the benefit that suits your needs and your current life.
Career with a Purpose

Career with a Purpose

With your job, you make a valuable contribution to improving patients' quality of life around the world.
Long-term Account

Long-term Account

Whether it's training, caring for family members, early retirement or a period of absence - the long-term account offers various time-off options.
Pension Plan

Pension Plan

At Fresenius, you receive an employer-funded company pension plan in addition to your salary.
Childcare Allowance

Childcare Allowance

If you have children, you can apply for a financial allowance which is transferred monthly in addition to your salary.
Health at Work

Health at Work

We offer you a wide range of sports, nutrition trainings and preventative services.
Direct Insurance

Direct Insurance

Fresenius supports you in setting up your direct insurance – so you can benefit from the attractive conditions of our Group agreement.
Accident Insurance

Accident Insurance

At Fresenius, you are covered for accidents every day of the year, anywhere in the world. In addition, you can also insure your family.
Individual Professional Development

Individual Professional Development

We promote you with professional development programs and support lifelong learning throughout your career.
Employee Discounts

Employee Discounts

We offer you to benefit from a program with attractive discounts on products and services from well-known retailers.
Corporate Catering

Corporate Catering

Our company restaurants provide you with freshly prepared meals every day.
Food Allowance

Food Allowance

You can purchase food and drinks at a discounted price in our company restaurants.
Company Medical Service

Company Medical Service

The company medical service is available for consultation, first aid in the event of occupational accidents or reintegration.
Transport Connection

Transport Connection

Most of our locations are very well connected to highways, bus stops or train stations.
Parking Lots

Parking Lots

Free parking lots are available at many of our locations.
Sports Activities

Sports Activities

Depending on the location, we offer a wide range of sports activities - from company runs and sports badges to tournaments and competitions.
Hybrid Working

Hybrid Working

Working from home or in the office or both? There are various offers for hybrid working that give you a lot of flexibility.
Employee Participation Program

Employee Participation Program

With Fresenius SHARE, we let our employees participate in the company's performance through a share program; in addition, we enable them to buy shares at very favorable conditions.
Tariff-based supplementary long-term care insurance scheme

Tariff-based supplementary long-term care insurance scheme

Employees covered by the collective bargaining agreement will be collectively insured by the employer against the risk of long-term care - without a health check.
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At a glance

Earliest possible start:

As from now

Job Type:

Permanent

Company:

Fresenius Kabi

Location:

Bad Homburg, DEU

Working condition:

Full-time

Job Function:

General Management

Reference number:

R-10007618

Publishing date:

05/22/2025

Please submit your application in English. As long as the job ad is online, you can apply quickly and easily.

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Your contact

Michelle Esinger
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We seek talents and perspectives

At Fresenius, we are convinced that combining different perspectives, opinions, experiences, cultures and values enables us to harness the potential that will make us even more successful. All job applicants are welcome.

All terms used in this job advertisement to denote persons refer to all genders equally.

Careers with a purpose

When it’s not just a job, but your calling. When you have an impact on people’s lives every day. When you can’t imagine doing something else. Then you know it’s Fresenius.