Global Quality Assurance Manager - Computer System Validation | Qualitätsmanager (m/w/d)

medac GmbH

Wedel, Schleswig-Holstein, Deutschland
Published Mar 10, 2026
Full-time
No information

Job Summary

As a Global QA Manager specializing in Computer System Validation (CSV), you will play a pivotal role in shaping and implementing global guidelines for computerized systems and data integrity across the medac Group. Your daily responsibilities will include overseeing the validation of GxP-relevant IT systems, developing CSV methods in collaboration with Global Process Owners, and conducting specialized training. A unique aspect of this position is the initial two-year assignment at the production site in Dessau to lead local validation efforts before transitioning focus. This role is ideal for a professional with a strong background in pharmaceutical processes and GAMP guidelines who enjoys interdisciplinary project work. medac offers an attractive package including up to 60% remote work, performance-based bonuses, and comprehensive professional development through their internal academy, making it an excellent opportunity for those looking to make a meaningful impact in the healthcare sector.

Required Skills

Education

Completed degree in Natural Sciences, Computer Science, Engineering, or a comparable qualification.

Experience

  • Professional experience in a GMP (Good Manufacturing Practice) environment
  • Extensive expertise in GAMP 5 guidelines for computerized systems
  • Experience in creating and revising global quality documentation
  • Proven track record in managing and maintaining the validated status of global IT systems
  • Practical experience in conducting professional training sessions

Languages

German (Fluent)English (Fluent)

Additional

  • Must be willing to work at the production site in Dessau (oncotec) for the first two years of employment. Proficiency in MS Office (Word, Excel, PowerPoint) and databases is required.