Minimum BA/BS in Information Technology, Chemistry, Life Sciences or Pharmaceutical Science- Must
MBA or Quality Management - Preferred
Minimum 10 years pharmaceutical and computer validation experience Must
Experience in the Pharmaceutical/ Biotechnology or Medical device industry- Must
Minimum 5 year's supervisory experience or proven leadership capability- Must.
Working knowledge of FDA compliance, specifically in 21CFR Part 11 regulations and GAMP guidelines- Must
Knowledge in IT standards, procedures, various platforms, configurations, project life cycles and change control systems/databases -Must
5 years' experience with a quality IT unit in the pharmaceutical, biotechnology, or medical device industries -Preferred
5 years' experience in regional or global role, in multicultural and matrix organizations- Preferred
Knowledge of computer software packages, such as: Microsoft Office (Word, Excel, Visio, Power Point)
Proven experience is cGxP supplier audits, audit reports writing and follow up.
Fluent English- Must