Elizabeth Waldorf is Director of Global Traceability and Standards at TraceLink. She is responsible for transforming global regulatory serialization and traceability regulations into product requirements for TraceLink’s portfolio of track and trace solutions. Elizabeth is a key contributor to TraceLink’s delivery of US, Brazil, China, South Korea, EU, Russia, India, Bahrain, Indonesia, Uzbekistan, Kazakhstan and UAE government compliance modules. Elizabeth is focused on transforming country regulations into standardized models for traceability implementations.
Starting before the US DSCSA regulation was passed, Elizabeth has been driving pharmaceutical compliance at the state level. Her effort has continued through the passing of the US DSCSA regulation to the present day. A believer in achieving interoperability and operational efficiency through standards, Elizabeth’s editorial contributions include the following guidelines: “GS1 US Implementation Guideline for Applying GS1 Standards for DSCSA and Traceability (release 1.2)”, “GS1 US Implementation Guideline for the GS1 Lightweight Messaging Standard for Verification of Product Identifiers (releases 1.0, 1.1 and 1.2)”, and “GS1 US Applying GS1 System of Standards to Pharmaceutical Chain of Custody (releases 1.0 and 1.1)”. With a vigilant eye towards accelerating onboarding of trading partners for DSCSA message exchanges using EPCIS, Elizabeth collaborated to develop the GS1 US Rx EPCIS Conformance Testing Program. Committed to industry pharmaceutical compliance readiness, she is working towards the development of future releases of implementation guidelines to reflect evolved requirements and learnings.
With a passion for thought leadership, Elizabeth joined the GS1 US Healthcare Executive Leadership team and has taken on various leadership roles spanning GS1 US and GS1 Global. She currently co-chairs the GS1 US Rx Secure Supply Chain workgroup and GS1 EPICS/CBV 2.0 MWSG. As a member of GS1 Architecture team, Elizabeth serves as the GS1 Architecture liaison to GS1 Mission Specific Workgroups for EPICS/CBV 2.0, Pharmaceutical Clinical Trial Processes and Biological Samples. Elizabeth previously co-chaired the GS1 Brazil Traceability, Global Traceability Standard, and the GS1 Lightweight Messaging Standard workgroups.
Elizabeth is also an active leader in other industry and standards organizations including Partnership for DSCSA Governance (PDG), Healthcare Distribution Alliance (HDA) and serves as tri-chair of the Open Credentialing Initiative (OCI)’s Policy and Architecture team. She brings together her multi-discipline experience to advance and accelerate the delivery of specifications and adoption of interoperable standards.
Before joining TraceLink, Elizabeth led Amgen’s global serialization and traceability initiatives, and drove adoption of GS1 standards across the company. In her 20-year tenure at Amgen, Elizabeth held numerous senior leadership roles managing cross functional teams in Global Supply Chain, Sales & Marketing, Enterprise Architecture, and Finance. Her leadership style and operational excellence mindset combined with business and information systems background have resulted in many successful implementations of process re-engineering and automation initiatives.