eCompliance Manager

Essential Requirements :

• 10-15 years of overall IT experience, and a minimum 7 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance
• Solid understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.)
• Solid experience in the development, implementation and lifecycle management of computerized systems in regulated environments
• Experience in quality management of Cloud, SaaS platform, mobile and digital application used in regulated environments
• Highly experienced in the operational management of GxP solutions including its related technologies to support the operation
• Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.)
• Experience in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space (e.g. ERP / SAP, MES, LIMS, CRM, IAM, etc.)

Desirable Requirements :

• Degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent.

Skills Required

Audit Support