100055 Fresenius Kabi Deutschland GmbH
Process Architect Quality Management / Complaint Management(m/w/x)
Full-timeOn-siteExperienced
Bad Homburg vor der Höhe
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FRFresenius Kabi Deutschland GmbH
Process Architect Quality & Complaint Management(m/w/x)
Bad Homburg vor der Höhe
Full-timeOn-siteExperienced
AI/ML
Nejo AI Summary
Designing global quality management processes, standardizing complaint and event management, and developing end-to-end process templates. Extensive hands-on experience in pharmaceutical/MedTech quality management platforms and digital transformation required. AI integration into quality processes, process flow documentation, and validation deliverables.
Requirements
- University degree in Life Sciences, Quality Management, Engineering, or related discipline
- Extensive hands-on experience in quality management process design, focus on Quality Complaint Management and/or Quality Event Management in pharmaceutical or MedTech
- Proven track record implementing modern quality management platforms (e.g. SAP QM, IQVIA, Veeva or comparable systems), including rollout and user adoption
- Demonstrated experience in digital transformation initiatives, including master data definition and governance, end-to-end process documentation, and validation-relevant deliverables
- Practical experience integrating AI and advanced analytics into quality management processes for efficiency, automation, predictive insights, and decision-making
- Strong knowledge of quality management principles, GxP regulations, validation requirements, and industry best practices in pharmaceutical and MedTech sectors
- Excellent analytical, problem-solving, communication, and stakeholder management skills, ability to translate complex concepts for diverse, global audiences and collaborate effectively across functions
- Proven project management capabilities, including leading cross-functional teams, managing multiple priorities in fast-paced environments, driving initiatives to completion, proactive and improvement-driven mindset, and willingness to travel internationally
Tasks
- Design global quality management processes
- Standardize Quality Complaint Management processes
- Optimize Quality Event Management processes
- Develop end-to-end process templates
- Maintain process flows and documentation
- Define critical process parameters
- Govern master data and data models
- Support Quality Management platform implementation
- Configure modern quality systems
- Integrate AI solutions for process efficiency
- Collaborate with IT and Quality teams
- Work with Manufacturing and Business stakeholders
- Lead global rollout of standardized processes
- Support system integration with existing infrastructures
- Collect and analyze user feedback
- Incorporate performance metrics
- Drive continuous improvement initiatives
- Ensure GxP regulatory compliance
- Partner with Quality Assurance
- Support validation activities
- Define testing protocols
- Execute compliant documentation
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAP QM
- IQVIA
- Veeva
- Artificial Intelligence
- advanced analytics
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
- 100055 Fresenius Kabi Deutschland GmbH
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FRFresenius Kabi Deutschland GmbH
Process Architect Quality & Complaint Management(m/w/x)
Bad Homburg vor der Höhe
Full-timeOn-siteExperienced
AI/ML
Nejo AI Summary
Designing global quality management processes, standardizing complaint and event management, and developing end-to-end process templates. Extensive hands-on experience in pharmaceutical/MedTech quality management platforms and digital transformation required. AI integration into quality processes, process flow documentation, and validation deliverables.
Requirements
- University degree in Life Sciences, Quality Management, Engineering, or related discipline
- Extensive hands-on experience in quality management process design, focus on Quality Complaint Management and/or Quality Event Management in pharmaceutical or MedTech
- Proven track record implementing modern quality management platforms (e.g. SAP QM, IQVIA, Veeva or comparable systems), including rollout and user adoption
- Demonstrated experience in digital transformation initiatives, including master data definition and governance, end-to-end process documentation, and validation-relevant deliverables
- Practical experience integrating AI and advanced analytics into quality management processes for efficiency, automation, predictive insights, and decision-making
- Strong knowledge of quality management principles, GxP regulations, validation requirements, and industry best practices in pharmaceutical and MedTech sectors
- Excellent analytical, problem-solving, communication, and stakeholder management skills, ability to translate complex concepts for diverse, global audiences and collaborate effectively across functions
- Proven project management capabilities, including leading cross-functional teams, managing multiple priorities in fast-paced environments, driving initiatives to completion, proactive and improvement-driven mindset, and willingness to travel internationally
Tasks
- Design global quality management processes
- Standardize Quality Complaint Management processes
- Optimize Quality Event Management processes
- Develop end-to-end process templates
- Maintain process flows and documentation
- Define critical process parameters
- Govern master data and data models
- Support Quality Management platform implementation
- Configure modern quality systems
- Integrate AI solutions for process efficiency
- Collaborate with IT and Quality teams
- Work with Manufacturing and Business stakeholders
- Lead global rollout of standardized processes
- Support system integration with existing infrastructures
- Collect and analyze user feedback
- Incorporate performance metrics
- Drive continuous improvement initiatives
- Ensure GxP regulatory compliance
- Partner with Quality Assurance
- Support validation activities
- Define testing protocols
- Execute compliant documentation
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- SAP QM
- IQVIA
- Veeva
- Artificial Intelligence
- advanced analytics
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Kabi Deutschland GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Fresenius Kabi Deutschland GmbH
Industry
Pharmaceuticals
Description
Das Unternehmen repräsentiert Produkte und Dienstleistungen im Bereich Trinknahrung und Anästhetika.
Not a perfect match?
- 100055 Fresenius Kabi Deutschland GmbH
Process Architect Quality Management / Complaint Management(m/w/x)
Full-timeOn-siteExperiencedBad Homburg vor der Höhe - 100055 Fresenius Kabi Deutschland GmbH
Process Architect Quality Management(m/w/x)
Full-timeOn-siteExperiencedBad Homburg vor der Höhe - Fresenius Kabi Deutschland GmbH
Process Architect Quality Management (QA/QC)(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - Fresenius Kabi
Process Architect Supply & Production Planning(m/w/x)
Full-timeOn-siteExperiencedBad Homburg vor der Höhe - Fresenius Kabi Deutschland GmbH
Process Architect - Inventory Planning(m/w/x)
Full-timeOn-siteExperiencedBad Homburg vor der Höhe