Tony Moir

• Leading multiple simultaneous IT projects with budgets between $500k to $5M.
• Delivering reliable solutions by overseeing software design, development, testing, implementation, and support phases of IT projects.
• Managing cross-functional project teams to ensure efficient allocation of resources and successful project completion.
• Led three Agile scrum teams of developers, product analysts, and QA resources to provide project and production support.
• Facilitated communication and collaboration among team members to solve complex technical challenges efficiently and effectively.

• Managed validated and verified enterprise level application deployment, upgrade, and data migration projects, from planning to completed execution
• Managed Veeva Upgrade Risk Assessments and Validation Analysis for multiple clients, ensuring 21CFR Part 11 Compliance requirements were met
• Managed the addition of new Veeva Functionalities for multiple clients, including: Data Migration from other systems, Veeva Rim Publishing and RIM labeling, Veeva Network Integration, Veeva Vault Security Model, Veeva eTMF, and Veeva QMS Vault refactoring
• Communicated and collaborated with the multiple business clients to improve System and Business processes and manage system changes and enhancements
• End to End GxP Testing of application and data changes
• Provided upper tier troubleshooting and support for multiple clients
• Performed technical project management duties

Technical Scope: Veeva Vault Platform, Veeva QualitySuite, Veeva RIM, Veeva Quality Docs, Veeva QMS, Veeva Quality Docs, Veeva Network, eTMF, Veeva Vault CDMS, Veeva CTMS, Endpoint IRT, and QPulse LIMS.

• Provided analysis and technical and/or administrative backup for systems and processes
• Technical Lead and Project Management on multiple Veeva related initiatives to integrate and improve connectivity with other supporting Validated and Non-Validated systems
• Mentored and developed team resources and processes providing standardized support procedures, Operations Management, Change Management, and 21 CFR Part 11 Validation processes for multiple Veeva modules and Vault types to facilitate changes and improvements in business process and clinical study data management
• Implemented changes to validated Veeva Vault Clinical, Quality, eTMF, and RIM applications
• Implemented integrations between Veeva Vault Clinical, RIM, and Microsoft Azure, ICON iRIS, SafetyVigilance, and Seagen’s own AI development effort
• Managed creation and execution of validation requirements, documentation, and testing for GxP systems and applications in ALM
• Developed high-quality documentation to support training efforts, helping employees fully understand new systems and procedures.

Technical Scope: Veeva Platform, Quality Vault, Clinical, eTMF, RIM, HP ALM, SafetyVigilance, Azure DevOps, FileZilla sFTP, and ServiceNow.

• Provided analysis and technical, administrative, and architectural skills to systems and processes
• Provided technical and business leadership for projects that successfully validated and deployed multiple Veeva instances and applications, in Initial implementation, Standard Operations and Management, and Change Management for multiple Veeva Vault QMS, Quality Docs, CDMS, and RIM Instances
• Architected integrations between eTMF, IRT, EDC, and CTMS systems
• Rationalized Validation and Specification information for multiple GxP systems
• Key Achievements: Implemented validated Veeva Vault CDMS application
• Implemented integrations between Veeva EDC (CDMS), Endpoint IRT, and Jarvis CTMS
• Implemented sFTP automation between Ascendis and multiple CROs
• Implemented API integrations between Endpoint IRT, Veeva CDMS, and Jarvis CTMS
• Streamlined and modified Project Management Validation and Documentation Methodology for GxP systems projects
• Managed creation and execution of validation documentation and testing for GxP systems and applications

Technical Scope: Veeva Platform, Quality Vault, QMS, RIM, and CDMS, Jarvis CTMS, Endpoint IRT, Azure DevOps, FileZilla sFTP, and Salesforce ServiceDesk.

• Providing analysis and technical and/or administrative backup for systems and processes
• Creating new and improving current PMO processes and training the business and external vendors to these new project execution requirements
• Led projects that successfully validated and deployed DocuSign with the Part 11 module, upgraded Argus Safety, TraceLink, and Compliance Wire, and provided Initial implementation and/or Change Management for multiple Veeva Vault QMS, Quality Docs, and RIM Instances
• Key Achievements: Implemented validated Veeva Vault QMS application
• Implemented validated DocuSign application
• Periodic upgrades to validated systems such as: Argus Safety, ComplianceWire, Veeva QualityDocs, Veeva RIM Vault, TraceLink
• Streamlined and modified Project Management Methodology for GxP systems projects
• Created and managed metrics and data management strategies for all GxP systems and applications
• Managed creation and execution of all validation documentation and testing for GxP systems and applications
• Managed support vendors and project management for all GxP systems and applications

Technical Scope: Veeva Vault, QMS, RIM, and PromoMats, TraceLink, DocuSign GxP, Insight Viewer, Publisher, and Viewer, ComplianceWire, Salesforce ServiceDesk, Argus Safety.

• Managed GxP validated enterprise class application and system upgrades and other IT projects across multiple departments and business areas
• Responsible for planning, communicating, budgeting, coordination, and any necessary escalations for multiple projects simultaneously to support the initiatives of the company and the creation of new PMO processes
• Responsible for streamlining obsolete PMO metrics and communications for multiple projects
• Managed relations with software and support vendors
• Simultaneously managed multiple projects spanning applications, infrastructure, and virtualization
• Key Achievements: Led the project to migrate enterprise class document management, change control and validation application to ensure quality while splitting the company’s regulatory and validation documents into four workstreams to split the functionality of the source system between four different applications
• Led multiple cross functional efforts within the company to ensure GxP and policy compliance
• Led the project to migrate the medical information and request system to the cloud, upgrading three different software versions and expanding functionality to ensure validated status for this highly FDA regulated software
• Consulted on and created elements of the new CMO process for all systems projects
• Led the project to replace and consolidate the entire West Coast facilities and safety ticketing system
• Led the project to virtualize access to three lab system software applications, migrating and architecting access for business critical lab personnel and processes
• Led the project to migrate domains and connectivity for 200+ pieces of lab equipment and their connected hardware

Technical Scope: Veeva Vault, Master Control DMS, Apptus, ALM, Smartsheet, MS Project, MDM, Numerous Lab Software systems.

• Managed Service Request, Change Management, Problem Management, and Issue Management for GxP system upgrade processes and projects
• Prioritized issues and communicated to the business and internal IT groups while working with external vendors to resolve those problems
• Created and reviewed required documentation for GxP validated systems
• Led projects including enterprise class application security assessment and upgrades, GxP validation documentation creation and review, data cleansing and troubleshooting issues with enterprise data and e2b transmission
• Resolved issues related to Argus Safety and Argus Safety Japan by utilizing internal support resources and vendor support from Oracle Support and other external vendors, ensuring resolution within agreed SLA parameters
• Performed regular database refresh processes and scripts code to ensure that error checking and logging is maintained for documentation and audit purposes
• Created initial and follow-up analysis and documentation for a large data management project involving disparate data sources to ensure regulatory compliance with Japanese and other national health authorities
• Directed the network segmentation process for enterprise class applications to ensure data and application security for validated information

Technical Scope: SQL, Oracle Argus Safety, Oracle Argus Safety J, GTrack (Trackwise), Axway Interchange, IBM Cognos, Fieldglass, Oracle Support, ServiceNow, Documentum eRoom, Documentum G2

• Led comprehensive optimization and streamlining of service request, problem and issue management, and data request processes
• Oversaw organization of business-critical information systems involving multiple external sources
• Key Achievements: Provided adhoc query design and maintenance using Oracle SQL, PL/SQL, Spotfire, OBIEE, and scripted solutions
• Utilized LEAN/Six Sigma methodologies to eliminate process inefficiencies producing an average time savings of 75%
• Decreased errors by 75% by refactoring the extract, transform, and load (ETL) processes of critical safety systems
• Created ticketing system metrics foundation by redesigning queues via optimization of related processes and automation

Technical Scope: Data Mining, SQL, Case and Event Reports (using TIBCO Spotfire), BI Publisher, VBA, Access, Argus, process automation on validated systems using SharePoint Workflows, Microsoft Flow, DocuSign, sFTP, InfoPath, HP ALM, ServiceNow

• Concurrently supported multiple SaaS projects through continuous process improvement practices
• Addressed key escalated issues and prevented scope creep
• Consistently achieved all development milestones in a time efficient manner while staying on budget
• Networked with crucial partners and customers to maintain top-tier service quality standards
• Provided input and created PMO processes for communications and control of project support across the department
• Key Achievements: Managed team providing support to up to 11 projects simultaneously while mentoring 4 technical support specialists and 3 outsourced support analysts
• Created PMO tracking method to manage schedules
• Reduced review time, automated routing, and normalized metric data through design and optimization of video training system
• Averaged 4.8 out of 5 satisfaction score from clients by creating strategy to monitor call volume, emails, tickets, and escalation methods, meeting or exceeding 100% of SLA deadlines

Technical Scope: Project Management, PMO Process, AWS, SaaS, Slack, JIRA, Confluence, ServiceNow, Excel and MS Project reports, UNIX monitoring

• Spearheaded leadership of system administration methods for a client base of over 9 million
• Supported process optimization, designed creative solutions for applications, and ensured peak adherence to customer SLAs
• Key Achievements: Utilized C# to design app-based solution ensuring 90% of orders and outages were allocated and automatically dispatched
• Oversaw and administered Ventyx FAS workforce Optimization and Dynamic Dispatch queue while maintaining perfect record of never exceeding SLA ticket closure guidelines
• Collaborated on system upgrades and verified minimization of downtime

Technical Scope: Ventyx Service Suite, IaaS, SQL, ServiceNow, MS Project, Visual Studio, Salesforce.com SourceSafe, C# scripting, WebLogic, HP ALM, Business Objects, SAP

• Managed metric solutions, executed requirements gathering, and designed unique decision-making tools for the Computing Services Business Operations department
• Key Achievements: Managed all functional aspects for a team of 5
• Created detailed metrics and reporting for UNITE, propelling PG&E as industry leaders in IT management, governance, and implementation
• Created a streamlined solution leveraging business objects and SQL in a metrics kiosk that removed duplication within reporting and dashboarding for department leadership

Technical Scope: ASP.net, SAP, Business Objects, CRM, Crystal Reports, SQLServer, MySQL, Xcelsius, TIBCO Spotfire, IIS, HTML/CSS Scripting, JavaScript, SharePoint Designer, VBA for Access and Excel, sFTP

• Headed metrics solution design, implementation, and maintenance for the Computing Services department
• Key Achievements: Improved average development time from 1 month to 5 days by producing a unique scalable process that tracked and simplified metric requests and unified 7 disparate processes
• Created Operations Support team and function to implement IT business process improvements

Technical Scope: asp.net, SAP, Business Objects, CRM Crystal Reports, SQL, Xcelsius, TIBCO Spotfire, IIS, HTML/CSS Scripting, JavaScript, SharePoint Designer, VBA for Access and Excel, sFTP, WebLogic