Program management of the implementation of a global eQMS system.

Elicititation and modeling of business processes in ARIS. Definition of  requirements for GxP-critical processes.

Management and execution of the Computerized System Validation for SAP Solution Manager (CHaRM) and  SAP S/4 HANA in GxP environment for an international company.

Project management of an implementation of a local eQMS implementation from initiation to closure.

Project management of the data integrity project from initiation to closure.

Project management of the initiation (process analysis, fit-gap, URS) and concept (RfP / system selection) phases for the implementation of a global eQMS system for an internationally acting group of companies.

Project management (ad interim) of the enhancements to processes and computerized system functionalities (SaaS) including CSV to improve pharmacovigilance processes for SARS-CoV2 vaccine.

Implementation of a serialization project for a virtual MAH comprising GS1 registration, EMVO onboarding as SPoC, NMVO contracting, alignment and modeling of serialization business processes,  implementation, configuration and validation of TraceLInk LSC SaaS (Brand Owner & EU Compliance) as Level 4 / Level 5, and connections to Contract Packaging Organizations, Third Party Logistics and EMVS/EU hub.

Analysis and restructuring of the program set-up. Support in RfP for future L4 system landscape consolidation (SAP OER / ATTP / TraceLink LSC) and Russia compliance. Revision of global validation strategy. Coaching of project management of global Russia compliance project. PMO set-up.

Indonesia and Ecuador Drug Traceability project management.

Set-up of testing strategy (data tests, end-to-end tests, pilot batch) for the onboarding project of two international CMOs to the MAH via TraceLink (SNX / SOM) for EU FMD.