Fusion Consulting
Senior Validation Manager(m/w/x)
Full-timeWith HomeofficeSenior
Frankfurt am Main
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FUFusion Consulting
Lead Validation & Test Manager(m/w/x)
Frankfurt am Main
Full-timeRemoteSenior
Nejo AI Summary
Developing and optimizing validation/testing frameworks for SAP and GxP systems at a Life Sciences IT consultancy. 7+ years in GxP validation/testing/QA, with deep GxP, CSV, GAMP 5, 21 CFR Part 11 knowledge required. Project-based work with diverse client engagements.
Requirements
- Bachelor’s or Master’s in Life Sciences, IT, Engineering, or related field
- 7+ years in validation, testing, or QA within GxP regulated industries
- Experience with SAP transformation or enhancement projects
- Deep understanding of GxP, CSV, GAMP 5, ISO standards, 21 CFR Part 11, Annex 11
- Strong leadership, stakeholder management, and communication skills
- Fluency in English; German is a strong plus
Tasks
- Define and manage validation frameworks for SAP and GxP systems
- Optimize testing frameworks to ensure compliance with global regulatory standards
- Oversee validation and testing across SAP, GxP, and digital systems
- Ensure consistency, quality, and compliance in testing activities
- Apply a risk-based approach to define and execute validation scope
- Drive CAPA management and conduct deviation investigations
- Perform root cause analysis for validation and compliance issues
- Serve as the central contact for validation and compliance activities
- Mentor validation and testing professionals to promote quality and compliance
Work Experience
- 7 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- SAP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fusion Consulting 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.
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FUFusion Consulting
Lead Validation & Test Manager(m/w/x)
Frankfurt am Main
Full-timeRemoteSenior
Nejo AI Summary
Developing and optimizing validation/testing frameworks for SAP and GxP systems at a Life Sciences IT consultancy. 7+ years in GxP validation/testing/QA, with deep GxP, CSV, GAMP 5, 21 CFR Part 11 knowledge required. Project-based work with diverse client engagements.
Requirements
- Bachelor’s or Master’s in Life Sciences, IT, Engineering, or related field
- 7+ years in validation, testing, or QA within GxP regulated industries
- Experience with SAP transformation or enhancement projects
- Deep understanding of GxP, CSV, GAMP 5, ISO standards, 21 CFR Part 11, Annex 11
- Strong leadership, stakeholder management, and communication skills
- Fluency in English; German is a strong plus
Tasks
- Define and manage validation frameworks for SAP and GxP systems
- Optimize testing frameworks to ensure compliance with global regulatory standards
- Oversee validation and testing across SAP, GxP, and digital systems
- Ensure consistency, quality, and compliance in testing activities
- Apply a risk-based approach to define and execute validation scope
- Drive CAPA management and conduct deviation investigations
- Perform root cause analysis for validation and compliance issues
- Serve as the central contact for validation and compliance activities
- Mentor validation and testing professionals to promote quality and compliance
Work Experience
- 7 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- SAP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fusion Consulting 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
Fusion Consulting
Industry
Consulting
Description
Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry.
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