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Lead Validation & Test Manager(m/w/x)
Beschreibung
As a Lead Validation & Test Manager, you will lead the charge in ensuring that validation and testing activities meet global regulatory standards. This role involves overseeing compliance across various systems while mentoring a team dedicated to quality and best practices.
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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
Ausbildung
Berufserfahrung
7 Jahre
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
Tools & Technologien
Sprachen
Englisch – verhandlungssicher
Deutsch – Grundkenntnisse
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Lead Validation & Test Manager(m/w/x)
Die KI-Suchmaschine für Jobs
Beschreibung
As a Lead Validation & Test Manager, you will lead the charge in ensuring that validation and testing activities meet global regulatory standards. This role involves overseeing compliance across various systems while mentoring a team dedicated to quality and best practices.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
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
Ausbildung
Berufserfahrung
7 Jahre
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
Tools & Technologien
Sprachen
Englisch – verhandlungssicher
Deutsch – Grundkenntnisse
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.
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