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