Geoffrey Wilson Email & Phone Number

California, United States

Systems/ProjectsIT Software Implementation• Reviewed and made recommendations as an SME for validation documentations IQ (Installation Qualification), OQ (Operations Qualification), and PQ (Performance Qualification) for various projectsIT Documentation updates• Updated Livelink training documentation/instructions , IT SOPsChange Control Management for IT Dept.• Drafted, engaged business, finalized, and control Change Control documents workflow for various Software patching, software and application updates , decommissioning applicationsActive Directory Validation project• Finalized Validation Plan and Validation Summary Report for Active Directory Validation Project• Managed the deliverable of Onyx Active Directory System Owner tasks and monitor the progress of the activities and coordinate the project status with the Active Directory Program ManagerSystem Compliance Assessments • Drafted, engaged business, finalized and controlled workflow for regulatory assessment of computer systems to determine the disposition of regulations governing the computer system (GxP, HIPPA, Privacy, Sarbanes Oxley)Livelink System Administrator (Acting), supported Livelink System Owner for Livelink maintenance / support• Record management, resolved service tickets in Integrated Service Management (ISM) as a part of the Resolver group and acting administrator for LivelinkLivelink Server and Data Center Migration• Utilized ALM (Application Lifecycle Management) to run Performance Qualification for Livelink server migration and validation project after Data Center Migration

Link Redirection Service (LRS)• LRS Update project is to support the EDMTeams Content Migration and redirecting links from the EDMTeams repository to various Documentum repositories, Sharepoint Online, BOX, and Sharepoint MyTeams • Generate and finalize the Design documentations for Link Redirection Service Update (SCA/ISA, Requirement, Design, Validation Plan, Validation Test Script, Trace Matrix, SOP)• Utilized ALM (Application Lifecycle Management) to complete Test ScriptsLivelink Data/Content Migration• Provided expertise for Proof of Concept data mapping for the first phase of the Livelink Content Migration• Developed the Livelink migration process and compiled business requirements for data migration• Engaged the Business and proposed the disposition of the source documents to the target repository based on the applicable governance documents• Authored three final iterations of the DMP (Data Migration Protocol) one for each Wave• Authored 22 Protocols and finalized 11 – Installation Operations Performance Qualification (IOQ) for business data migration• Conducted successful UAT and UAs with business reps• Directed the focus of the Business and BAs for migration activities to bring back the project schedule that was derailed due to resource changesEDMTeams Content Migration Proof of Concept• Involved in high level use case gathering, scope analysis, and feasibility by analyzing the security, audit trail, metadata, link redirection, and limitation of the migration• Involved in the Migration Capability analysis for each target repository• Delivered the Migration Service Overview Documentations such as Capability Matrix for each repositories, Migration Process, and proposed Migration Servicer Offerings for varies cost, complexity, and value to client• Generated Pre Migration Validation Report Template for Data Discovery findings and Post Migration Validation Report Template for Migration Outcome• Presented the Migration Tool Recommendation

Power BI and Integrity Validation• Project manager managing all aspects internal and external to validate systems21 CFR Part 11 and EU Annex 11• Facilitated and supported the analysis and development of the Gap Assessment for the client to be in compliance with regulatory• Facilitated the developement Compliance RoadMap based on the Gap Analysis reportDesign Control Training• Managed the preparation and distribution of training material based on client’s regulatory observation and needs• Managed the resources readiness for scheduling and conducting the Design Control TrainingEtQ Reliance Complaint Module• Delivered the Verification and Validation documents including the User and Admin SOPsEtQ Non Conformance Reporting• Involved in managing the remediation off the implementation of EtQ NCR. e-Signature Assessment• Project Manager to complete and close up projectGlobal IT and Regulatory Audits• Presenting Global Audit status and updates the client management• Review of Audit reports and make suggestion for changes• Manage the Global Audit timeline, risk, and budget• Conduct Business meetings for various aspects of the Global AuditLOGIC 510(k) Rewrite• Project manager to support assessments and writing submission draftRegulatory Affair Consultant• Supported various needs of the client on an as needed basisData Integrity and Assessment Report• Project Manager to support client with an internal analysis of systems and processes to identify GAPs and needs

Farifield, Ca

Fairfield, Ca

San Francisco, Ca

Farifield, Ca

Vacaville, Ca

Fairfield, Ca

Fairfield, Ca

Vallejo, Fairfield, Dixon, Ca

Bs Business Administration, General Management, Entrepreneurship

Activities and Societies: BHON Business Honors Program College of Business CSUS, Beta Gama Sigma, Phi Kappa Phi, Delta Epsilon Iota.

Associate Of Arts (A.A.), Liberal Arts And Sciences, General Studies And Humanities

Activities and Societies: Fairfield Suisun Rotary Scholarship, General Scholarship Solano Community CollegeGraduated with High Honors

Associate Of Arts (A.A.), Liberal Arts And Sciences/Science And Quantitative Reasoning

Activities and Societies: Fairfield Suisun Rotary Scholarship, General Scholarship Solano Community CollegeGraduated with High Honors