IT GxP Validation Manager
Workplace: Lund, Sweden
Expires: September 5, 2025
Manage IT-related validation and qualification activities for a biopharmaceutical company, ensuring compliance with GxP guidelines and improving IT Quality Management Systems within a collaborative international environment.
Main requirements:
  • Bachelor’s degree in information technology, Computer Science, or related field.
  • Proven experience as an IT Validation Manager or similar role.
  • Strong knowledge of GxP validation and qualification including GAMP 5, 21CFR Part 11, and Eudralex, Vol 4 Annex 11.
  • Deep understanding of IT processes and best practices.
  • Excellent communication and interpersonal skills.
  • Leadership and management capabilities.
Responsibilities:
  • Manage validation and qualification activities related to IT systems.
  • Develop and enhance IT Quality Management System (QMS) policies and procedures to create an efficient framework.
  • Participate in IT audit activities and ensure timely closure of IT audit findings.
  • Engage in projects involving system validation.
  • Collaborate closely with IT and Quality Assurance colleagues.
Required hard skills:
  • GxP validation and qualification expertise
  • GAMP 5 compliance
  • Knowledge of 21CFR Part 11 regulations
  • Familiarity with Eudralex, Vol 4 Annex 11
  • IT process management and optimization
  • Audit management
Recommended hard skills:
  • Experience with pharmaceutical IT environments
  • Project management skills
Soft skills:
  • Excellent communication
  • Strong interpersonal skills
  • Leadership and management abilities
  • Collaborative mindset
Natural languages:
  • English (Proficient)
  • Swedish (Working knowledge)
Cultural skills:
  • Work effectively in an international and dynamic corporate culture
  • Patient-centric approach to work
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