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Global CSV Lead

vor 2 Monaten

Frankfurt am Main, Hessen, Deutschland SciPro Vollzeit

Global CSV Lead

As a Global CSV Lead, you will be responsible for managing IT validation strategies and providing guidance to other departments and sites in relation to computer system validation. This role requires a strong understanding of quality risk management and GxP regulatory frameworks.

Key Responsibilities:

  • Develop and implement quality management processes for IT systems implementation projects
  • Ensure compliance with regulatory requirements such as 21 CFR Part 11, GMP Annex 11, and GAMP5 guidelines
  • Design and develop electronic business solutions in a GxP environment
  • Execute and create validation and testing strategies
  • Oversee the review, enhancement, and implementation of IT quality processes, standards, and systems
  • Optimize processes and life cycles in relation to global validation
  • Lead and execute internal and external audits, with accountability for managing IT service providers and ensuring supplier compliance

Requirements:

  • Studies in Life Sciences, Computer Science, Business, or a related field (or equivalent relevant experience)
  • Several years of experience in computer system validation
  • Familiarity with quality risk management and GxP regulatory frameworks
  • Strong knowledge and practical application of FDA and EU regulations and other compliance standards
  • Fluent German and English skills

What We Offer:

  • Exciting work environment where you can implement your expertise
  • Attractive salary compensation
  • Innovative approach
  • Flexible working hours
  • 30 days of holiday time each year

About Our Client:

A global contract manufacturer specializing in pharmaceuticals, providing comprehensive services from active ingredient production to final drug packaging. It supports pharmaceutical and biotech companies in key therapeutic areas, with a strong focus on quality and regulatory compliance across its international facilities.