We have a current permanent position open for an Director It in Cologne-Germany in a world leading biopharmaceutical company.
This client is a global biopharmaceutical company to design to accelerate the discovery and development process for biopharmaceutical drugs, while reducing the cost of production
Key Responsibilities:
- Lead and conduct rollout project for new and updated IT systems at the EU sites together with the local expert teams
- Liaise with global projects teams as representative of the EU sites and their requirements
- Harmonize user requirement to ensure a standardized use of IT systems among the EU Sites
- Drive and support local activities for Computerized System Validation
- Author and review Sops for IT System lifecycle Management and Data Integrity
- Author and review SOPs for It System Lifecycle Management and Data Integrity
- Lead and support EU Quality project besides IT and support further department activities
Key requirements:
- Must be familiar with general GMP requirements of EMA, FDA and other relevant standards
- Must be familiar with specific GMP requirement for Computerized System
- Experience working in a Quality Assurance role in a GMP Life Science environment
- Previous experience with Computerized system validation and Data integrity
- Project management experience
- Proven track record of successful managing IT project, e.g. for computerized system rollout and implementation
- Excellent oral and written communication skills in English and German