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Fusion Consulting
3mo ago

Lead Validation & Test Manager(m/w/x)

Frankfurt am Main
Full-timeRemoteSenior

Description

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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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

Education

Master's degree

Work Experience

7 years

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

Tools & Technologies

SAP

Languages

English – Business Fluent

German – Basic

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