Projects Executed
Pharma Artwork Change Management Projects
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Filled Global Artwork Lead role for Post-Approval Change projects, including spinoffs, legal entity mergers, site name changes, and MAH transfers.
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Ensured on-time implementation of >3,000 artwork changes, maintaining regulatory compliance while avoiding discards.
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Took on extra role of Pack Site Program Integrator for the EMEA region.
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Co-authored a Program ‘Playbook’ as part of lessons learned.
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Note: project ongoing through 2024
SAP Automation for In Vitro Diagnostic Regulation (IVDR)
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Developed business concept and SAP requirements for automated batch update solution to Finished Goods.
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Coordinated 7 sites for UAT, training, data cutover, Go Live, and Hypercare.
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Acted as business liaison with IT.
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Delivered thorough documentation and knowledge transfer prior to completion
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Eliminated 9 x part-time FTEs freeing up people for higher-value add work
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Read more about IVDR here.
Pharma Serialization:
GTIN Transfer Project
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Developed GTIN change process to transfer 853 SKUs to spinoff company.
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Goal was to avoid replacing the SKU.
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Project-managed serialization master data change execution with 3 finished good packaging sites in Europe.
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Implemented custom E2E milestone tracking for management visibility.
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Found a way to complete the project 4 months ahead of schedule.
Master Data Management Deepdive for in vitro diagnostics manufacturing plant
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Completed hands-on review of 387 finished good products.
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Reported back 96 recommendations with action items.
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Areas of focus: process improvement, documentation best practices, and prioritized list of data cleansing opportunities.
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Acted as a catalyst for a broader Data Governance initiative.
Data Governance messaging for the world's largest logistics company
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Provided external perspectives to CFO and Global Steering Committee for Master Data Management.
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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
