SUMMARY:

Global Project Manager with multiple successful end - to-end implementations and upgrades of ERP, web, mainframe projects using SDLC, PMBOK, SEI, IEEE, CMMI, ICH, GAMP, V-Model, Waterfall, RAD, Iterative, Agile, SCRUM, AIM, ASAP, Six-Sigma, Lean

EXPERTISE:

GAMP-5, ICH, CA, EU, FDA: 21CFR Part 11, 50, 54, 56, 58, 210, 211, 312, 314, 701, 807, 812, 814, 820; ISO-9000-1, ISO-14000, ISO-13485, QSR, NQA-1, GAAP, revenue cycle, SOX, HIPAA, IT Controls, COBIT, GRC, Privacy, PCI, PII/PHI, Security, Electronic Health Records, Insurance

TECHNICAL SKILLS:

Tools: MS Word, EXCEL, PowerPoint, Visio, ACCESS, MS Project, Keynote, QuickBooks, Adobe, Niku, Clarity, Google, Outlook, Exchange, Apple Mac iOS, Lotus Notes, SharePoint, TFS, Skype, WebEX, LiveMeeting

Technical: COBOL, CICS, JCL, MVS, Z/OS, AS-400, iSeries, MMIS, ABAP, Java/J2EE, MS SQL, SQR, SSIS, SSRS, SSAS, ASP.NET, HANA, BI, BW, BO, BOBJ, BODS, Crystal, Oracle Essbase, OBIEE, R/OLAP, OLTP, Hyperion, SAS, R, JMP, MicroStrategy, BigData NoSQL Apache, Hadoop, HDFS, Storm, ElasticSearch, MapReduce, Pig, Hive, Oozie, Flume, Puppet, GIT Lab, GIT Hub, TFS, JIRA, RICEFW Objects, Lotus Notes to Documentum, FileNet to Documentum, Livelink migrations, SharePoint upgrades, RHEL Linux, UNIX, Web 2.0, webMethods, Websphere, EP, MDM, BASIS, Netweaver, OO, OD, RDBMS, DB Sybase, Informix, Oracle, DB2, MQ, Fusion, API, EDI, HL7, BizTalk, RFC, BADI, BAPIs, iDocs, TIBCO; SOA, SaaS, AWS, Virtual, Cloud, VM Ware, Tivoli, EMC NAS/SAN Storage, HP-UX, AIX, BEA, Weblogic, MQ, SOAP, XML/XSLT, EJB, DNS, Proxy, TCP, IP, EDI, HTTP(S), SSL/TLS, Networks, LAN/WAN, controllers, routers, switches, cables, firewalls, AirWatch, LogRhythm, Qualys, Citrix, Netscaler, VPN, LDAP, SSO, Active Directory, Oblix, SiteMinder, Cache, controllers, voice, media, WebRTC, SIP, IVR, PBX, ACD, VoIP, Cisco IOS, mobile BYOD, wireless, eMDR, eHR, Tidal, Remedy, LSMW, LIMS/ELN, PDM, PLM, MES, SCADA, DWH, ETL, Informatica, Trillium, Cognos, Teradata, HP QC, WinRunner, LoadRunner, ALM, QTP, TAO, Photoshop, Sony Vegas Pro, Final Cut Pro

PROFESSIONAL EXPERIENCE:

Confidential, Orlando, FL

Project Manager

Responsibilities:

• Facilitated transformation to Kronos Confidential v8 from v6 on-premise to virtual cloud, integration with SAP ECC 6.0 HANA, BW/BI, MDM, HR, ESS, MSS, Benefits, Taleo Talent Management, Payroll, Assets, FI-CO, Ariba, Revenue Recognition, PS, SuccessFactor eLearning, Hyperion Financials and Performance Management, WFM, Workday, Informatica DWH/ETL. Developed interface to legacy Peoplesoft v8 to convert and migrate HCM, Financials, Assets, Benefits, Sales, Marketing to SAP ECC6.0, Cloud, Teradata, Informatica MDM, BigData environments
• Manage IT system infrastructure, personal computers, network services, networks, servers, enterprise applications, email, internet, BYOD mobile personal device connectivity, telephony, IVR, VoIP, Genesys, Avaya, PBX, pagers, radios, faxes, VPN, audio-video, CCTV, SIP, WebRTC, NetApp, TelNet, WAN, WLAN, LAN, VLAN, Wi-Fi, routers, gateways, modems, switches, controllers, ports, firewalls, MPLS, Nortel, Orion monitoring, data integrity, master data management, information security and integrity, InfoSec, identity and access management (IAM), security, IT Controls, segregation of duty, Privacy, POS payment cards, PCI-DSS, backup recovery, help desk services. Schedule, coordinate 35 cross-functional onsite-offshore technical, DevOps, infrastructure, functional, employees, contractors, SaaS team resources
• Devised strategy for SQL, NoSQL BigData architecture, landscape for digital, multimedia, images, visuals, feeds, streaming, texts, engineering drawings, Auto-CAD, Pro-Engineer, UG, CATIA, GIS, storyboards, messaging, chats, social media, audio, videos, photos, e-Commerce, merchandising, sales, strategic targeted, prescriptive and predictive Marketing, SEM, SEO, tags for analytics, event management, production, rendering, wireless integration, live streaming with OSS Spark and Storm, campaigns, TV commercials, promotions, managed permits, authorizations, intellectual property, entitlements
• Integrated OBIEE, 12C database, MapR, Hive, and provisions for analytics with Splunk, OSS Oracle R Advanced Analytics on Hadoop, R, and SAS 9.4, Tableau tools. Cross-platform configuration management for WIN, Solaris, HP-UX, AIX, Mac X with Puppet
• Supervised install and use of OSS for real-time, near real-time ingestion Splunk, Oozie, Hive, Flume, Golden Gate, and Oracle EE with MapR. ElasticSearch, Oracle Exadata advance search, storage, replication/failover and scalability with Hadoop Distributed File System; Executed IT system and 3rd party audits, security, IAM, SIEM, BigData OSS Splunk, Puppet, Cloudera implemented for cloud and on-premise, IDS, penetration, vulnerability, GRC, SSAE16, IT Controls, COBIT

Confidential, San Francisco, CA

Project Manager

Responsibilities:

• Planned, scheduled $10M EDI ANSI XII, 4010 to 5010, ICD 9-10 conversion, recruited, hired 200 cross-functional onsite-offshore reports composed of IT, consultants, functional, partners, agencies
• Integrated EDI and ICD changes to MITA architecture including interfaces ERPs, MITA, Confidential mainframes, DB2, Cognos, TIBCO, Teradata, WebSphere, DWH/ETL, LIMS/ELN, EPIC, legacy Cerner, trading partners, and government agency interfaces, testing, FDA Confidential validation of SOA, as well as process, equipment, embedded, firmware solutions. Supported plans Peoplesoft 9.0 Cutover, Final Preparation, eLearning, Core Financials, Ariba Go-Live
• Approved Waterfall release of upgraded v6 to6x Kronos, Workday, Confidential integrated with SAP ECC 6.0, BI 7, clocks, timekeeping, payroll, FI-CO, AP, Ariba, OpenText VIM/ICC, HR, ESS, MSS, Benefits
• Upgraded Point Of Sale payment card processing system, kiosks, EMV, chips/readers, integrated RFID serialization, IV/V
• Developed scope and change control documents, MS Project Plan, WBS, and Niku Clarity reports
• Created and deliveredteam communications, status reports to stakeholders, business, and technical team. Planned and executed integration, cutover, Go-Live, release management plans. Revised BCP, DRP SaaS plans, created reports
• Revised budget, financial estimates, forecasts, track, monitor and report T&E, P/L, earned value, ROI
• Planned, scheduled and executed hardening and patching for SOA, firewalls, SCCM, Cisco unified communications, IVR, VoIP, Orion, Nortel switches, controllers, routers, VPN, tunnels, audio-video conferencing, cameras, CCTV, biometrics, doors, alarms.
• Managed structure, design and releases using BigData tools, Hadoop, MapR, ElasticSearch, SPLUNK, HUNK, Flume, HIVE, Tableau, and Documentum repository

Confidential, Bellevue, WA

Project Manager

Responsibilities:

• Devised and executed project plans for roadmaps, SDLC, Agile, SCRUM plans, deliverables, schedule, scope, budget, resource work plans for delivery of pre-payment on premise, cloudVLAN, LAN, WAN, integration, near real-time, real-time monitoring, streaming, messaging, logging, data capture and transformation, data management, change controls, steering committee status reports
• Created SOA strategy, built landscape, deployed TOGAF technology roadmap for SQL, NoSQL, BigData, ElasticSearch, Puppet, Hive, Oozie, Security, payment card transactions PCI-DSS, identity and access management, LDAP, SSO, Active Directory, foundation, ingestion, processing, aggregation, analytics, spatial and Graphical Information Systems (GIS) business intelligence reporting, Oracle R, V12C databases, Hadoop, MapR, alerts, texts, messages, queries, flash reports, dashboards, drilldown analyticsin virtual HyperV, on-premise systems
• Evaluated, authored, revised Dev, custom requirements, user stories, resolved test defects, improvement plans for audio, video, pictures, web, RTC, SIP, Trunk, streaming, telcom, conferencing, call recording, answering machines, modems, gateways, routers, switches, transceivers, multiplexers, UCCX, real-time monitoring, efax/fax, landlines, PBX, VoIP, 911, radios, paging, CAD, CAM, PLM, transmission, fibers, wired, wireless BYOD mobile for analog, digital, multimedia services, e-Commerce, Call Center, Help Desk, BCP, DRP
• Established aggressive patching, configuration, upgrades for middleware, WDSL, EMA, Fusion, JAVA, Websphere, SAP ECC 6.0, JD Edwards, COBOL, CICS, VSAM mainframe Financials, HR, MM, SCM, Logistics. Evaluated, approved training, Confidential, IV/V

Confidential, Reading, PA

Project Manager

Responsibilities:

• Developed remediation plans for InfoSec, security, SIEM, IAM, privacy, CMS Meaningful Use, ACA, HIPAA, COBIT, IT Controls, SOX, HIPAA, POS payment card security PCI-DSS, NIST-800, ISO-27001, 21 CFR Part 11, FDA Confidential findings, CAPA, deviations, change management. Gained approval for MS Project Plan, timeline, budget, resources, audit results. Spearheaded team to secure corrective and preventive actions, testing, reports using Waterfall method
• Updated PMO and stakeholders with project plans, status reports, and metrics. Facilitated team, stakeholder meetings
• Created training materials, delivered training on governance risk and compliance, IAM, security, PCI-DSS, Cisco hardening, patching, configuration, and system changes to support testing, cutover, eLearning and Go-Live for Peoplesoft v9.0 Financials
• Audited EPIC and legacy GE Centricity and Cerner electronic health records systems, Lawson Financials, MM, EDI, billing, claims, revenue recognition, BI systems, LabWare LIMS, ELN, Empower LIMS, Labs, Clinical Trials, Pharmacy PLM/PDM, Cisco, Orion unified communications, IVR, VoIP, Help Desk, Call Center, VIM/ICC, EDMS Documentum audit reports, improvement plans

Confidential, Louisville, KY

Project Manager

Responsibilities:

• Formulated MS Project Plan, scope, budget, change management, testing, unit, system, integration, performance, user acceptance testing deliverables. Used PMI PMBOK, SDLC, Agile custom development, and Waterfallrelease to production methods
• Executed legacy Pharmacy transformation from AS/400 to SAP ECC 6.0, Financials, GL, CHIP, EBT, Accounting, Assets, Ariba, AP, Livelink VIM/ICC, Procurement, MDM, MM, SRM, WMS, Taxes, HR, ESS/MSS, Payroll, clocks, Kronos WFM, Taleo, benefits, insurance, Compensation, Ariba, Documentum, IXOS, SuccessFactors, BW/BI, security, identity and access management (IAM), PCI-DSS, POS, Active Directory, LDAP, Cisco Unified Communications
• IntegratedIBM mainframes, SAS, LIMS/ELN, Advantage, Encounters, Edge, HIE, MU/ACA for Medicare, Medicaid reporting with EDI, claims, revenue recognition, Advantage, Encounters
• Retired legacies i-Series, Centricity, McKesson, Cerner data migrated to MITA architecture EPIC, Confidential i-Series EHR
• Chaired PMO and executive steering committee, change control, supplier, and cross-functional onsite-offshore team meetings for 70 direct reports on $5M budgeted project. Recruit, interview, hire
• Gained approvals for Agile and Waterfall project deliverables and administered Documentum, IXOS, SharePoint, Clarity, GIT Lab, GIT Hub, TFS. Stored project deliverables in EDMS
• Audited IT systems for compliance to governance model, SOX, HIPAA, Privacy, NIST-800, ISO-27000, PCI-DSS, and IT Controls. Created audit reports, action plans, risk and mitigation plans, issue management and continuous improvement plans

Confidential, Jackson, MS

Program Manager

Responsibilities:

• Built MS Project Plans, RICEFW and Clarity plans, hired resources, created scope and change management plans. Hands-on day-day operations manager and single point of contact for the project. 270 reports and $200M budget, P/L, TCO, ROI, earned value
• Devised cutover, data cleanse, enrichment, integration with Teradata, WebSphere, Informatica, DWH/ETL data conversion and migration, legacy decommission plans using the onsite-offshore team and Waterfall method
• Approved project deliverables and administered document repositories SharePoint, Clarity, TFS, JIRA, Documentum system maintenance, updates. Reported status to PMO, steering committee
• Released new SAP ECC 6.0, BI 7.0, APO, Portals, CRM, e-Commerce, SD, MM, PP, Costing, CC/kiosks for e-Commerce, PLM, Ariba, OpenText VIM/ICC, POS, internet sales, services, Analytics, Marketing, Kronos WFM, HCM, ESS/MSS, OM/PA, Benefits, Taleo, Timekeeping, Insurance, ADP, Payroll, Vertex, Travel, Expense Management, SuccessFactors eLearning, Compensation, FI-CO, MDM, SAS, R, SRM, Red Prairie WMS, RFID Serialization, MRP, Z/OS Mainframe, Cerner, EPIC, McKesson, Help Desk, Call Center, Emergency system, radios, RF devices, IVR, PBX, VoIP, Cisco networks tested, validated and released to production environment
• Integrated government agencies, hospitals, clinical, doctor’s offices, education/schools, EDI upgraded to 5010, PCI-DSS
• Chaired change control board, technical, functional, DevOPs, infrastructure, networks, servers, unified communication, business intelligence resource team meetings tracking and controlling issues, risks, problem and incident management. Delivered training
• Liaison to State for CMS, ACA, Medicare, Medicaid ICD9-10, EDI 4010/5010 conversions and reporting, Revenue Recognition, Pharmacy, InfoSec, PCI (payment cards, POS, kiosks, EMV), CIP, HIPAA, SOX, ITIL/ITSM, Workday, IT Controls, Quality, training
• Maintained updated plans, WBS for Peoplesoftv8 Break-fixes, testing, validation, and production support, SLAs

Confidential, Chicago, IL

Program Manager

Responsibilities:

• Built a 75 member cross-functionalglobal onsite-offshore team, $ 15M budget, MS Project and Clarity plans, RICEFW trace and Waterfall implementation. Created scope and change control SOP and training. Assessed, mitigated risks, actions, deployment
• Facilitated SDLC, business process analysis, design control meetings, core team, PMO and steering committee status meetings
• Implemented virtual SAP ECC 6.0, Auto-Identification, RFID Serialization project including modules, applications: FI-CO, SD, HR, MDM, CRM, e-Commerce, BI/BO, MM, IM, PP-PI, SRM, Red Prairie WMS, MRP, LIMS/ELN, Mettler-Toledo weighing, EBR, MES, SCADA, PLCs, Vertex, TUBS, Kronos, Workday, Taleo, SuccessFactors, IVR, Help Desk,EPIC, Cerner EHR, mobile BYOD

Confidential, Pittsburgh, PA

Program Manager

Responsibilities:

• Devised strategy and MS Project Plans for upgrade from SAP 4.6c to ECC 6.0 All-In-One implementation (BI/BO/BOBJ, FI-CO, BPS, BCS, HR, ADP, SD, CRM, Kronos WFM, Taleo, Ariba, Teradata, Vertex, PS, SRM, QM, PM, PLM/PDM, Maximo EAM, MM, MDM, BackOffice, PP-PI, SCM, APO, Inventory Mgmt, LO/LE, WMS, Batch Records, MES, SCADA
• Established governance, audited for compliance to SOX, COBIT, SAS 70, HIPAA, security, GxP, CDRH (QSR, ICH, 21CFR Part 11, 210, 211, 510K), security, NIST-800, ISO-27000. Created, delivered audit results, project status to PMO and steering committee
• Managed Vendor and Material Master Master Data Management, metadata cleanse, de-dupe, standardization, enrichment
• Supervised technical build of interfaces and verified test and validation results for DWH, DataStage, ETL, Dispatch to ECC 6.0, SAP MDM, Z/OS mainframes, CTMS, EPIC, McKesson, Cerner, ECD, IVR, CRM, telephony, IVR
• Led onsite-offshore team of 90 direct reports sponsored by $10M budget for releases in 32 countries
• Created SuccessFactors eLearning materials and delivered SAP training
• Designed and supervised cutover, readiness, data conversion, migration, Go-Live plans
• Chaired business process analysis, requirements BRD, BPPs, specifications, testing, change management, PMO meeting

Confidential, San Francisco, CA

Program Manager

Responsibilities:

• Released a global automated blood pooling, assay, sample archiving/traceability medical device
• Managed creation of GxP deliverables and archives; integration of SAP ECC 6.0, BI/BO/BOBJ, SD, CRM, MDM 5.5, Help Desk, CTMS, EPIC HIS, Pharmacy, Clinical Trials, Red Cross, Maximo MRO conversion, migration, validation, cutover, readiness, Go Live
• Established and maintained project governance, standards, project deliverable templates, document and data control, and configuration management for Waterfall methodology. Administered Clarity, SharePoint, Documentum repositories
• Reported status of MS Project, Clarity Plans to 60 reports, PMO and steering committee. Created, maintained $5M budget

Confidential, Boston, MA

PMO Project Manager

Responsibilities:

• Implemented TrackWise, Confidential records for complaints, adverse events, service orders management, reporting to Agency
• Designed infrastructure for Agile deployment of virtual Serialization, Auto-ID, RFID, LIMS/ELN, mobile
• Created 120 member team of onsite-offshore reports, and a $3M budget for the global implementation of TrackWise
• Documented FDA Confidential strategy, GxPdeliverables, integration, user acceptance testing, data cleanse, conversion, migration, build, release, production loading, performance, storage, BCP/DRP, SLA, HP Quality Center Test Management for GMP 21 CFR Parts 11, 210, 211, 820, 510K compliance. Designed and legacy decommissioning plans
• Oversight for integration of SAP ECC 6.0, Netweaver, APO, FI-CO, CRM, SolMan, MDM 5.5, BOBJ, BI, SD, HR, ADP, IM, MM, PP, SRM, WMS, Kronos, ECD, MES, SCADA, EBR, Mettler-Toledo weighing, CTMS, EPIC, Pharmacy, CMS, MMIS-MITA legacy Z/OS mainframes architecture reporting MU/ACA, Revenue Recognition, ICD9-10, EDI ANSI XII, unified communications, call center, help desk, ITIL/ITSM. Facilitated development of VMP, VSR, requirements, RTM, URS, FRS, CAPA, IQ/OQ/PQ, deviations, CAPA
• Developed Gap analysis, MS Project Plans, stakeholder Clarity Workbench reports, business cases, RFx, MSA, SOW, contracts
• Managed issues, risks, CAPAs, change management, cutover, integration, testing, business process analysis, design, Go-Live
• Devised communication plans, facilitated, delivered project communications.
• Created end user training materials

Confidential, Phoenix, AZ

Senior Project Manager

Responsibilities:

• Developed MS Project Plans, testing strategy and plans, cutover, readiness, data cleansing, conversion, migration, FDA GxP validation plans using Waterfall method assisted by 120 reports, and $25M budget, accruals tracking, P/L, ROI status reports
• Deployed release of SAP ECC 6.0 for the Retail market w/online internet sales B2B/B2C-Systems, upgraded from customized 4.6c: Finance, GL, Accounting, Treasury, SolMan, AP/AR, Ariba, Kronos, Workday, HR, ADP, MDM, TUBS, Vertex, Taxes, Hyperion, Inventory, MRP, SRM, WMS, ECD, CTMS, McKesson, EPIC,LIMS/ELN, Documentum, IXOS interfaces
• Implemented HP QC 9.2 system for testing, defect management, metrics, risk management training
• Created GxPSOPs for datacenter startup and shutdown, disaster recovery, business continuity, security, IAM and delivered training
• Integrated Peoplesoft Financials, Grants, Treasury, ADP, Bank routings with SAP ECC 6.0, testing, IV/V executed
• Assessed SolMan Road Map, revised roadmap to align with FDA, GxP procedures and communicated map, and provided training

Confidential, Chicago, IL

PMO Project Manager

Responsibilities:

• Upgraded Peoplesoft v8 to v9 Financials, Hyperion, BI/BO, Accounting, HR, supply chain, Ariba, Kronos, clocks, Taleo, ADP, Taxes, for integration with SAP, non-SAP, Confidential AS/400, Z/OS mainframes during merger-acquisition project
• Built 250 onsite-offshore team reports, PMO processes for status reporting to PMO, core team and steering committee.
• Designed and executed RICEFW tracking database and closure procedure. Created MS Project plan, communications plan, scope document, SOPs for IT systems. Facilitated change management, PMO, steering committee, issues and risks, team meetings
• Audited SOX, IT Controls, privacy, HIPAA, PCI-DSS, security, SIEM, IAM, NIST-800, ISO-27000, COBIT, IT Controls, Six Sigma
• Devised and executed testing strategy, readiness, cutover, Go-Live Plans and executed POS, EMV, chips, readers, kiosks
• Administered and updated Documentum, Niku Clarity, SharePoint applications containing project deliverables

Confidential, San Francisco, CA

Senior Project Manager

Responsibilities:

• Developed MS Project Plan for retiring legacy NovaManage, FileNet electronic document management systems and deployment of OpenText Livelink, VIM/ICC using PMI PMBOK SDLC Waterfall methods. Authored GxP validation deliverables, including risk assessment, change controls, requirements, RTM, URS, FRS, TS, IQ/OQ/PQ, VMP/VSR, Confidential training materials, delivered training
• Built cross-functional team of 50 reports, a business case, charter, scope tracking, $3M budget, P/L, accruals, ROI, earned value
• Collaborated with QA, Regulatory, legal, vendors, subcontractors on requirements, CAPA, FDA 21CFR Part 11, GxP compliance
• IntegratedEngineering ECOs in CAD/CAM, CATIA, Unigraphics, Pro-Engineer, PLM, PDM, Documentum, TrackWise, NuGenesis and Labware LIMS,* LIMS, MES, SCADA, QUMAS, SAS, Oracle eClinical, CTMS, Clinical Trial DBs, EPIC and Cerner electronic health records systems, ECD, embedded, firmware, process equipment, help desk, call center unified communicationssystems
• Performed Gap assessment, executed audits for IT Controls, SOX (302, 404), ISO-17799, COBIT, HIPAA, developed plans, reports
• Facilitated requirements gathering, business process analysis, design, specifications, setup, configuration, customization, integration

Confidential, Charlotte, NC

Project Manager

Responsibilities:

• Implemented Oracle EBS 11i/ASCM (AR, AP, GL, PA, OM, PO, INV, CRM, Ariba, PLM/PDM, SCM), ADP, Taleo, BI
• Managed reporting framework for MITA, HIE/EHR, Z/OS mainframes, Netezza, DB2, Control M, Teradata
• Created GxPproject deliverables per SDLC, MS Project Plan, testing, conversion, migration, requirements, RTM, risk assessments, feasibility studies, CAPA, deviations, URS, FRS, TS, VMP, VSR, design, integration, IQ/OQ/PQ, MDL, training
• Upgrades to MITA analysis, reporting framework NuGenesis and Labware LIMS, JD Edwards World, EnterpriseOne, Peoplesoft v8x, SAP, QUMAS, SAS, Oracle eClinical, ECD, EPIC, Documentum, TrackWise, CTMS, Citrix, EAM Maximo integration with Financials, Siebel CRM, e-Commerce, B2B, B2C interfaces, AS/400, OS390 mainframes, EDI, Gentran, Mercator
• Facilitated audits, IT Controls, SOX (302, 404), ISO-17799, COBIT, HIPAA, supplier audits, Six Sigma improvements plans

Confidential

Project Manager

Responsibilities:

• Devised strategy and deployed MITA reporting framework Oracle 11i E-Business Suite implementation per CMMI SDLC of SAP 4.6C Financials, BI, OM, PA, Ariba, SCM/Service Contracts, Red Prairie WMS, *LIMS, MRP, CTMS, eClinical, EDI, EPIC, SAS, ECD, MES, SCADA, RFID, Logistics. Oversight for URS, FRS, TS, testing, IQ/OQ/PQ, risk assessments, BCP, DRP, VMP, VSR, deviations
• Responsible for MS Project Plan, metrics, business case, charter, budget/financials, proposals, resources, training
• Audits performed: vendor, internal audits, SOX (302, 404), ISO-17799, COBIT IT; 21CFR Part 11, 58, 210, 211, GAMP-4, HIPAA
• Facilitated GxPdevelopment of IQ/OQ/PQ validation development and improvements, corrective actions, IV/V, FDA inspections
• Responsible for data warehouse, transactions, billing, ADP/Payroll, Taleo, Crystal Reports, testing, data conversion and migration