▪ Partnered with business to design and implement SaaS GxP systems, including Veeva QualityDocs, Veeva QMS, TraceLink, DocuSign Part 11, and ComplianceWire LMS among others. Managed system deliverables and advised business on technical design, configuration, and validation strategy. Managed migration of legacy data into new systems.▪ IT owner of GxP Veeva Vaults, ComplianceWire LMS, LearnShare LMS, DocuSign Part 11, and other GxP applications.▪ Managed cross-functional project teams consisting of internal and external resources to deliver system implementations and ongoing enhancements to GxP systems including Veeva Vault (Quality, RIM), SAS LSAF, Argus Safety Database, and others.▪ Authored or reviewed all system deliverables: validation packages, SOPs and other procedural documents, training plans and materials, and end user communications.▪ Managed vendor relationships, including development of project SOWs, managed service agreements, and ongoing licensing and support renewals.▪ Partnered with business, vendors, and other stakeholders to develop and review capability roadmaps to set budget and project priorities.▪ Served as IT SME for GxP internal audits in preparation for FDA preapproval audit. Worked with head of IT and other stakeholders to develop audit responses and execute remediation plans.▪ Scoped and led GxP gap assessment project to review systems across R&D space against procedural and regulatory controls. Partnered with business owners and QA to document remediation efforts via CAPA process.▪ Recruited and managed Scientific Computing Administrator responsible for primary IT support of lab and scientific applications.

Responsible for implementation, validation, system administration, and system support for GxP applications.--Led implementation of ComplianceWire Learning Management System (LMS), including multiple system integrations with Workday HRMS, Veeva EDMS, and Okta SSO. Managed cross-functional team of internal resources (QA, IT, HR), as well as external resources including technical, validation, project management, and organizational change management (OCM) from multiple vendors. Developed process for Halozyme organization to define role-based training curriculum, reducing compliance risk. --Led pilot implementation of IDBS E-Workbook ELN system. Collaborated with resources from across research and product development groups to define system requirements and configuration. Managed technical implementation of the ELN and worked with project team to define ongoing pilot tasks to ensure requirements were tested thoroughly, including continuous refinement of configuration in response to user feedback. --Project manager for Windows 10 upgrade, lab imaging storage, and other IT projects.

Following the Genoptix separation from Navigate/Novartis, transitioned with the Genoptix IT team back to Genoptix full-time.--Responsible for IT compliance functions, including oversight and revisions of policies and procedures, IT system user access reviews, training requirement definition, and participation in the IT security and risk management committee.--System administrator for Enterprise Quality Management System (EQMS, MasterControl). Prior to departure, coordinated with vendor to scope project to upgrade and enhance Quality Event Management (QEM) processes in system.

As part of Genoptix sale agreement and Novartis separation agreement, reported to Navigate BioPharma for duration of Genoptix IT separation. Responsible for validation strategy of transition projects to ensure data integrity and compliance with company policies and applicable regulations and controls.--Author of Master Quality Plan for Genoptix/Navigate IT transition program, aligning Novartis project management and Quality policies used as primary governance document for 30+ individual IT transition projects.--Defined and supervised validation strategy for 18 individual system transition and separation projects subject to GxP, SOX, and other controls. Systems included SaaS, externally hosted applications, and on-premise installations. Systems represented multiple functional areas across the business: Enterprise Quality Management System (EQMS, MasterControl), Financial Management System (Microsoft Dynamics/Great Plains, ReQlogic), IT Service Management System (ITSMS, ServiceNow), Laboratory Information Systems (Genoptix custom/bespoke applications, Clinical Trial Data transfers, Environmental Monitoring Software (REES), and others. --Defined Quality strategy for onboarding laboratory applications used in research & development and clinical trial testing to Novartis application inventory, as well as redeployment of applications on new Novartis hardware for end users.--Defined requirements, onboarding process, and oversight for external IT Quality contractors to assist with creation of project deliverables.

As part of Business IT team, responsible for computer system validation, Quality oversight of IT systems, and ensuring compliance with applicable regulations, controls, and standards. Collaborated with other IT resources and users from a variety of departments to develop requirements, implement validation strategies, and ensure ongoing change control and compliance of IT business applications.--Assisted with implementation of Novartis corporate standards for Information Governance & Management (IGM) with limited resources, including preparation for internal and external audits.--Defined and executed flexible validation strategy for multiple enterprise systems, including EQMS (MasterControl), ITSMS (ServiceNow), and Financial Management (MS Dynamics/Great Plains) as project core team member and validation lead while maintaining compliance with applicable regulations (GxPs, SOX, Novartis IGM and ICE requirements) and industry standards.--Authored standard operating procedures and work instructions to support system implementation and sustainment in alignment with GxPs, ITIL standards, and other applicable controls.--Implementation of Novartis Information Systems Risk Management (ISRM) document framework at Genoptix, including update to 70+ local IT policies and procedures and complete revision of IT training matrix for IT and non-IT employees.

Responsible for computer system validation, Quality oversight of IT systems, and ensuring compliance with applicable regulations, controls, and standards. Partnered with QA, business users, other IT staff, and external vendors to develop and execute validation strategies for a variety of enterprise systems. Served on project core teams to identify requirements and select appropriate solutions for business needs.--Developed internal policies for computer system validation with Quality Assurance and Software Test Engineering staff that would be compliant and flexible to accommodate both internal custom software development and configuration and implementation of commercial off-the-shelf software (COTS).--As project core team member and GIS validation lead, determined efficient validation strategy for multiple enterprise systems including Learning Management System (LMS, Saba), Manufacturing Execution System (MES, Camstar), Product Lifecycle and Document Management System (Agile), and ERP (JD Edwards EnterpriseOne), while maintaining compliance with GxPs and industry standards such as GAMP 5, including sustainment strategy for change control to maintain system compliance. --Core team member for selection and implementation of Enterprise Quality Management System (EtQ). Developed and executed validation strategy for QEM processes including CAPA and audits.--Managed the creation and execution of validation/SDLC deliverables using both internal and external resources.

Managed IT internal training program for 600+ employees and contractors worldwide. Developed and delivered training to IT staff on key quality systems. Developed and presented quality and compliance-related metrics for IT management. Reviewed and approved computer system validation and change control documentation.--Designed and deployed a streamlined training curricula and process for IT staff resulting in improved training compliance of more than 40% within 90 days--Developed compliance metrics and presented to CIO and other senior leadership within and outside IT on a monthly basis--Developed and delivered exception/CAPA training for IT staff, closing a large GMP-compliance gap within IT--Represented IT as business owner on electronic document management system (EDMS), change control, exception/CAPA, and training systems governance and operations committees; reviewed proposed system changes and implementations and gave requirements as IT business owner

Supervised IT Quality staff contractor. Developed and delivered training to IT staff on key quality systems. Developed and presented quality and compliance-related metrics for IT management. Reviewed and approved computer system validation and change control documentation.--Defined and deployed document control process for IT-controlled work instructions and key system development lifecycle (SDLC) documentation--Managed review and revision of IT-controlled documents that were due for biennial review; identified document owners and ensured all documents were brought up to date--Assisted with the development and deployment of controlled templates for key system development lifecycle documents (SDLC)

Developed and deployed training program for IT staff worldwide, including personally delivering training on document control and change control. Assisted with deployment of unified IT change control system. Coordinated accounts for IT users of EDMS and all users of IT change control system.--Requested by CIO and other high-level IT management to define IT training requirements and author training process; successfully deployed training program to 500+ employees and contractors worldwide--Worked with TrackWise development team as a business analyst to help define user requirements and workflow for unified IT change control system--Developed training requirements, user work instruction, and account management process for IT change control system deployed to all IT staff and several hundred business owners of IT systems

System administrator for EDMS (Qumas eDocCompliance) and exceptions/CAPA system (TrackWise). Developed custom reports for EDMS (Oracle, Crystal Reports). Wrote and executed change and validation documentation for controlled system changes.--Wrote first version of EDMS application management procedure, later used as a model for all application management documents at Biogen IDEC.--Streamlined system governance model for TrackWise application to ensure that all sites/business areas were represented during governance meetings--Worked with multiple departments worldwide to define requirements and a standard set of document control metrics to develop first custom reports for Biogen IDEC EDMS--Developed key reports on controlled documents to support sale of Oceanside facility to Genentech

Helped deploy new EDMS (Qumas eDocCompliance), including developing requirements and developing and delivering end-user training. Developed documentation for Corporate Quality Documentation group. Helped define QA-controlled workflow in Biogen IDEC EDMS, including key suggestions for workflow management still in use by all QA Documentation departments.--Participated in development of training for new EDMS; successfully trained several hundred users at Oceanside facility--Helped author procedures for new Corporate Quality ----Documentation group used to implement Biogen IDEC global standards and practices

Supported QA Documentation group as business administrator for EDMS (Documentum). Developed process and delivered end-user training on electronic document archive. Developed databases (MS Access) for tracking change control and lot release documentation.--Worked with representatives from IT, Regulatory Affairs, and QA to define requirements and identify new EDMS system--Worked as part of corporate process reengineering effort to streamline change control process and develop database for managing change control data--Worked as part of corporate process reengineering effort to streamline lot release process and develop database for managing lot release data

Tracked approvals on QA-controlled documents, including validation protocols and manufacturing equipment change requests. Processed QA-controlled document changes and issued production copies of manufacturing batch records.--Business analyst for QA Documentation on EDMS team; defined workflow process for controlled document management in Documentum.--Led document control department effort to migrate controlled document storage from server/folder to EDMS, allowing version control, automated periodic review, and overall increased compliance--Developed process and training for electronic access to controlled documents, allowing retirement of paper-based document binders and increasing document control department efficiency