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Lead Validation & Test Manager(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 7 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- SAP
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Lead Validation & Test Manager(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 7 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- SAP
Über das Unternehmen
Fusion Consulting
Branche
Consulting
Beschreibung
Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry.
Noch nicht perfekt?
- Fusion Consulting
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