HI Impact Services

Biography

Summary: During a longstanding career in various continents and countries some common characteristics surface:

-Strong people management skills; developing skills and expand the use of capabilities (create a safe environment for experimenting new capabilities.)

-Change Driver by new vision/concept; governance and systems.

-Pro-active/ entrepreneurial mindset

-Result oriented, by coaching people resources to improve their contributions

-Provide Strategic and tactical direction; Based on goals & objectives for an organizational unit/ department; define and implement changes in processes/ structures (functions, roles and responsibilities) in conjunction with drilled down goals & objectives for sub units/ departments and individual members of the team.

-Implement improvement plans programs for :

System Development life cycles; including some of the key activities in it (Requirements gathering/ definition; Functional design and Testing.)

Information management in various functional areas

Implement Quality system control models for:

•Sarbanes Oxley

•C-GxP (Good Manufacturing/ distribution/ laboratory/ Pharmaco Vigilance Practices)

o21 cfr part 11 electronic records/ signatures

o21 cfr 820.30 Design controls

oEU Directive 93/42/EEC medical devices and guideline MEDEV 2.16 (Software as a medical Device)

o GVP’s according to Regulation (EC) No 726/2004 and Directive 2001/83/EC (former Eurolex Volume 9A)

•Privacy (EU requirements for USA based international companies (Safe Harbor ))