Lee Shields Email and Phone Number

• Global responsibility for I.T. Compliance within Leica Microsystems for FDA, SOX and GDPR. Developed the templates for FDA validations across several software platforms used globally throughout Leica . Expert at building and leading global validation teams to incorporate FDA V-model methodology from Validation Planning, User Requirements and Technical Specifications, Risk Analysis, Work Instructions, DQ, IQ, OQ and PQ through to issuing the Validation Report. • Global responsibility for I.T. Security within Leica Microsystems, liaising closely with Global Infrastructure to improve network security and DNS health, improving patch management and cadence of patches for servers and workstations, reduction of vulnerabilities. Improving Application security and working with Threat Management Centre to ensure the implementation of common security best practices. • Reporting to Global I.T. Director at Leica Microsystems, accountable for all SAP and SAPBW servers globally (32 countries). Responsible for developing and delivering a strategic business roadmap for SAP ERP. Account and Relationship Manager for the various outsource partners, including managing daily operations, future and strategic planning and communicating at various levels across multiple teams and partners to ensure a high level of operational performance is maintained.

- Daily have responsibility for Global SAP and SAP Business Warehouse Systems. - Interfaces into and out of SAP, SAP Business Connector. - Handheld Terminal setup and config to SAP for Bar-coding 1 dimensional and 2 Dimensional via SAP CONSOLE , Unique Device Identifier , SAP Script Outputs.- Responsible for outsource contracts and daily management of 3rd party relationships. - SAP Upgrades from 2.2.f. through to E.C.C 6- Compliance responsible for Sarbanes Oxley and FDA compliance within IT. - Certified to perform FDA validations of Computer systems, have performed many FDA IT validations of SAP systems and Project Life-cycle Management systems over the past 10 years.