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Projects Executed

Pharma Artwork
IVDR
GTIN Label Pharma

Pharma Artwork Change Management Projects

  • Filled Global Artwork Lead role for Post-Approval Change projects, including spinoffs, legal entity mergers, site name changes, and MAH transfers.

  • Ensured on-time implementation of >3,000 artwork changes, maintaining regulatory compliance while avoiding discards.

  • Took on extra role of Pack Site Program Integrator for the EMEA region.

  • Co-authored a Program ‘Playbook’ as part of lessons learned.

  • Note: project ongoing through 2024

SAP Automation for In Vitro Diagnostic Regulation (IVDR)

  • Developed business concept and SAP requirements for automated batch update solution to Finished Goods.

  • Coordinated 7 sites for UAT, training, data cutover, Go Live, and Hypercare.

  • Acted as business liaison with IT.

  • Delivered thorough documentation and knowledge transfer prior to completion

  • Eliminated 9 x part-time FTEs freeing up people for higher-value add work

  • Read more about IVDR here.

Pharma Serialization:
GTIN Transfer Project

  • Developed GTIN change process to transfer 853 SKUs to spinoff company.

  • Goal was to avoid replacing the SKU. 

  • Project-managed serialization master data change execution with 3 finished good packaging sites in Europe.

  • Implemented custom E2E milestone tracking for management visibility.

  • Found a way to complete the project 4 months ahead of schedule.

MDM Master Data Management
We Love Data Podcast

Master Data Management Deepdive for in vitro diagnostics manufacturing plant

  • Completed hands-on review of 387 finished good products.

  • Reported back 96 recommendations with action items.

  • Areas of focus: process improvement, documentation best practices, and prioritized list of data cleansing opportunities.

  • Acted as a catalyst for a broader Data Governance initiative.

Data Governance messaging for the world's largest logistics company

  • Provided external perspectives to CFO and Global Steering Committee for Master Data Management.

  • Co-produced a podcast and participated in a Q&A panel discussing topics like: why do it, consequences of not doing it, how to start, do's and don'ts, where to learn more.

Clients: past and present

Merck Logo
Siemens Healthineers
Thermo Fisher Logo
DB Schenker Logo
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