This position will be responsible for defining and maintaining global GxP and R&D application services. The successful candidate will have extensive experience with pharmaceutical and Biotech IT systems, vendor management, cross-functional team management, CFR part 11, GAMP 5, and Sarbanes Oxley regulations, systems validation, and change control.
This position will provide leadership to the Application Services team and the company. It will consult with the business to achieve successful GxP and R&D system development and completion of the IT department’s objectives, projects and priorities. He or she will provide work direction, development coaching and performance feedback to Application Services staff while establishing and maintaining positive relationships with relevant business partners.
Two to three years of experience support Sarbanes Oxley Information Technology General Controls (ITGC).
Working knowledge of CFR part 11 requirements and direct experience with systems implementation in a validated environment.
ADDITIONAL KNOWLEDGE AND SKILLS DESIRED: