Led migration of thirty-seven thousand regulatory documents and their associated metadata from Veeva Vault RIM to an in-house system due to a corporate acquisition.Using ALM (Application Delivery Management), wrote and executed Operational Qualification test scripts for GxP validated applications. Reported, tracked and resolved defects. Designed, performed and guided business representatives in User Acceptance Testing. Traced business requirements to validated test results.Using Biovia Qumas Electronic Document Management Software (EDMS), published, managed and tracked project related FDA 21 CFR Part 11 compliant documents. Created, edited and routed content for approval.Using ServiceNow, initiated, tracked, resolved and reported on incidents, problems and change requests throughout the project including Hypercare.Using Veeva Vault Regulatory Information Management (RIM), analyzed metadata, created custom reports and migrated clinical, nonclinical, regulatory, quality, safety, literature references, pharmacovigilance, quality and labeling documents including virtual documents in submission binders from Veeva RIM to Generis Cara data management platform.Using the Generis Cara Platform, directed migration activities in development, validation and production environments. Performed information technology administrative activities ensuring business workflows, configuration and taxonomies aligned with regulatory department goals. Executed data query language (DQL) queries for data analysis and corrective activities.

Conducted detailed stakeholder interviews in an $11 million drug discovery digitization project in preparation for an aggressive technology transformation to Acoustix tubes. The successful implementation of the software resulted in faster turnaround times for screening cycles, higher quality of data, and reduction of human error.Deployed an inventory management and workflow management system for the Compound Management and Distribution department using Rancher Kubernetes Engine, Docker with REL 7, Windows VDI environments, PostgreSQL, and Amazon Workspace, integrated with various RESTful services, and scientific lab instruments, resulting in faster turnarounds and nineteen system retirements. Recognized with two W. E. Upjohn Awards for volunteering to test all aspects of the deployment while customers focused on business-critical operations.Harmonized cell line information across WRDM to improve search capability and to protect intellectual property by creating a central database and front-end web application using Biovia Biological Registration for cell line entities using Agile delivery, partnering with development teams and stakeholders, conducting interviews, documenting workflows, gaps, insights, and key findings.

Implemented and supported customized LabVantage LIMS for a pharmacogenomics lab in a validated GxP environment, enabling faster innovation, more efficient lab operations, and seamless compliance with regulatory requirements such as the Clinical Laboratory Improvement Amendments (CLIA) and the Food and Drug Administration (FDA).Recognized with two W. E. Upjohn Awards for accurate requirements gathering and successful implementation of the LIMS including new Ion Torrent and NextSeq (Next Generation Sequence) workflows.

Delivered informatics solutions by conducting interviews, analyzing the best cost-efficient options, documenting requirements, collaborating with technical teams, and providing training and support to end users.Deployed an animal welfare management system for Comparative Medicine, resulting in clearer transparency for regulatory agencies and audits concerned with the care of animals in clinical trials.