Cloud Quality Manager

Harvey Nash is looking for a QM/IGM related to the qualification/validation of Cloud Services for a 3 + month project in Switzerland.

Requirements

- Experience with Validating GxP relevant applications in a vendor Cloud environment
- Experience with managing a large Cloud based validation/qualification projects
- Experience in defining a GxP qualification strategy and plan for a large Cloud based infrastructure/platform
- Experience with performing a vendor evaluation and defining a governance model between Novartis and a cloud provider such as Microsoft
- Understanding of the business requirements for a platform from the perspective of the owner of a GxP relevant, validated application
- Comprehensive regulatory compliance knowledge (FDA, EU, MHRA, ICH) and practical application to the GxP regulations regarding computerized systems and platforms, including 21CFR Part11 and EU Annex 11
- Understanding of the various predicate rules driving the various platform qualification requirements
- Business experience in one of the primary businesses within the Pharma industry (eg, manufacturing, clinical development, quality control, etc.)
- Direct experience in providing these services to a large, multinational pharmaceutical company
- Strong understanding of the MS SharePoint platform including O365, Yammer, SP2013 and MS Azure and the various implication from a data integrity, security and privacy perspective in relation to a large pharmaceutical organization

Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred)