Ryan Williams Email & Phone Number

Denver, Co, Us

Partners with the Food and Drug Administration (FDA) managing multiple Information Technology (IT) projects within the Office of the Commissioner (OC), Office of Regulatory Affairs (ORA) and Center for Biologics Evaluation and Research (CBER).Expertise managing Blanket Purchase Agreements (BPAs) including IT projects with contract ceilings up to $100M while adhering to the FDA’s Enterprise Performance Life Cycle (EPLC) Framework and NIST 800-53 Standards & Guidelines.Works directly with the government Contract Officer Representative (COR) for completion of all contract-related requirements and deliverables. Coordinates and delivers all project requests, gathering user feedback via users’ surveys and interviews, and leads process and project improvement initiatives to increase system use and adoption across FDA sites.Leads response for government Requests for Information (RFI) & Request for Proposal (RFP) for various government agencies leading to successful contract wins.

Greater Denver Area

Project Management & Requirements Lead for the FDA STARLIMS integration.Translates business requirements into system changes, enhancements, and defect corrections.Provides support for the STARLIMS implementation, and integration of applications with laboratory instruments.Facilitates meetings, system configuration, development evaluations, and site acceptance testing.Work with program and centralized team to configure the system based upon analytical testing requirements, configure/troubleshoot instrumentation issues, and maintain instrument controllers.Configures the STARLIMS application in all aspects including Electronic Laboratory Notebook use and Inventory Management.Provides instrument specific knowledge regarding instruments, instrument controllers, and their integration with a LIMS. Performs installation, configuration and integration of instruments and instrument controllers.Provides coordination with equipment manufacturers to install, maintain, and troubleshoot instruments and instrument controllers.

Longmont, Colorado

IT Project Manager & Systems Specialist supporting the Quality Assurance, Quality Control, Regulatory, Learning and Performance, and Environmental & Safety departments.Work with clients to understand business models, processes, and priorities to deliver the right scalable solution that includes process re-engineering, procedural changes, system modifications, and new systems.Create use cases, scripts, and process diagrams identify the business needs and implement the right solutions to meet cost and compliance objectives.Develop ROI project calculations and portfolio presentations.Business Intelligence Lead supporting Manufacturing, Quality, Learning & Performance, & EH&S and at the Amgen Colorado site.Develop and maintain Universe infrastructure for Business Objects Universe Design Tool 3.1 and 4.0 platforms and manage Cognos 10.2 reports and data structure for clients.Train and work with clients to develop key process reporting solutions that meet CFR 21 Part 11 compliance and decrease operating costs.Create and execute validation documents for systems in a regulated CFR 21 Part 11 GMP environment. Work as the Project Manager for IS Projects which includes creation of a Charter, resource identification and allocations, schedule creation and management, project updates to management, and lessons learned from projects.Facilitate management and team meetings to identify, prioritize, and deliver project management updates of IS projects.Generate presentations for the upper management, which outline issues and possible IS solutions as requests by users.Act as a single point of contact for client groups regarding Information System requests, issues, and escalation.Own Change Control records for implementation, maintenance, and decommission of Information Systems.Coordinate and own Nonconformance and Corrective Action records for Colorado Information Systems Department.

Ms, Information Systems Health Information Technology Management

Mba, Pharmaceutical Management And Healthcare Administration

Ba, Psychology