As an IT Business Partner, lead the team to support GxP Systems for Quality, Regulatory, Safety, Clinical, and Manufacturing & Supply Chain. ► Actively engage with stakeholders from both business and IT groups to gain alignment of approach and prioritization of technology strategy. ► Partner with senior IT and Business leaderships in developing strategic plan and gain alignment on timing for investments on new business capabilities.► Ensure that technology architecture, applications, processes, support operations and governance are aligned to the strategic business initiatives.► Lead the team to support various SaaS applications including new systems implementations and ongoing support. ► Support M&A activities to ensure IT integrations are implemented effectively. ► Third Party Risk Management initiative.Business Applications: Veeva QualityDocs, Veeva QMS, Veeva RIM, Veeva PromoMats, ComplianceWire, MasterControl, Tracelink, Argus Safety.

Independent Lifesciences IT Consultant supporting organizations in a GxP environments.► Pre-Approval Inspection (PAI) readiness support to ensure compliance and data integrity. ► Conducted system assessments and partnered with business on remediation activities. ► Defined new and assessed & updated existing SOPs to ensure compliance and address gaps.► Conducted trainings on IT procedures as they relate to information security and data integrity.► Managed deployment of Veeva RIM (Regulatory Information Management) and Veeva QMS (Quality Management System) systems. ► Project and Program Management. ► Computer Systems Validation (CSV) - write protocols, Test scripts, Validation Plan, Validation Report.► New solution selections to address business needs (RFI/RFP). ► Manage Systems Retirement program.► Implemented DocuSign Part 11 GxP Solution.Business Applications: Veeva Quality Docs, Veeva RIM (Regulatory Information Management), Veeva QMS, Veeva Quality Docs, ComplianceWire, Inventory Management, DocuSign Part 11

As a Business Relationship Manager, partner with business globally to address their needs.► Actively engage with stakeholders from both business and IS groups to gain alignment of approach and prioritization of technology strategy. ► Partner with business to make technology decisions that deliver significant impact and value.► Supported development and implementation of roadmaps for each functional area.► Evaluated and selected key solutions like Project and Portfolio Management (PPM) and Ideation tool for R&D.► Led deployment of a new Learning Management System (LMS).► Supported divestiture and acquisition projects to ensure smoother transition and protecting company assets.Business Applications: Agile PLM, Cornerstone Learning Management System (LMS), various R&D tools, Quality and Regulatory systems

As a Business Relationships Manager, led the global business solutions team to support Manufacturing, Supply Chain, Quality and Product Development. ► Partner with business leaderships across all sites to support the local business needs and support their strategic requirements. ► Led the teams during SAP implementation phases – integration testing, UAT and post go live support.► Defined the application roadmaps to support company growth.► Led the legacy application decommissioning project. Defined data retention and data access plans and processes for these applications.Business Applications Supported: Agile PLM, SAP PLM, SAP PPM, ETQ, Loftware, Camstar MES, Kinaxis Rapid Response and other manufacturing systems

Oversee launch of small to large projects for Camstar Manufacturing Execution System (MES) software, including development projects, defining deployment strategies, creating project plans, managing resource requests, and ensuring that project deliverables both adhered to timelines and met customer expectations.► Defined deployment strategy for a global non-conformance reporting (NCR) system project for medical device company.► Launched project for new MES implementation and a project to expand existing MES solution to new facility for two separate semiconductor companies.

Led global application development team including new application implementations, application upgrades, application integrations, MES implementations and ERP migrations. Provided IT leadership for six manufacturing and one R&D site. ► Led capital project of $5mm to set up applications in a new manufacturing facility in Asia.► Reduced applications management budget by consolidating and virtualizing applications, resulting in savings of over $500k YOY in maintenance and license costs.► Established procedures and shared services to manage division-wide applications, resulting in extended service hours and increased expertise to support applications globally. ► Established processes and procedures for 24/7 service desk, resulting in increase of first call resolution and decrease in call abandon rate.► Created SAP deployment road map for SAP deployment for Cardiac Rhythm Management Division of St. Jude Medical► Managed staff of 8 direct reports and 47 indirect reports in three locations.► Oversaw annual budget of $7mm.► Led 24x7 Service Desk team to support operations globally.► Established PMO to streamline IT effort. ► Led teams in implementation and technical support of enterprise application portfolio, including ERP, MES, PLM/PDM, Content Management and other core business applications.► Oversaw vendor management, including new vendor and solution selection.► Partnered across divisional business and global IT leadership to identify related goals, introduce common solutions and reduce expenses.Business Applications Supported: SAP ERP, QAD 8.5E ERP, Siemens Team Center Engineering TCE PLM, Rockwell MES (Factory Talk Production Center - FTPC), PROMIS MES, BizTalk ETL, SharePoint, Facilities Management System

Previous positions at St Jude Medical:► Sr. Manager, ERP Services► Manager, ERP Services► Group Leader, ERP Services► Sr. Programmer Analyst

As a consultant at Avaya Communications and Lucent Technologies, provided support globally on MFG/PRO ERP and during SAP ERP migration. Delivered training on Services module of SAP to Avaya users in Argentina, Mexico, France and Netherlands.Business Applications supported: QAD MFG/PRO 8.5E

As a consultant at Ethicon (New Jersey) and Caterpillar Inc. (Peoria IL), involved in the analysis, design and development of number of enhancements in MFG/PRO ERP in all MFG/PRO modules. Business Applications supported: QAD MFG/PRO 8.5E

► As consultant at Allen Bradley India (part of Rockwell Automation Group USA), managed the implementation of Distribution, Manufacturing and Finance modules of MFG/PRO. Led blue printing, training, conference room pilot runs and data conversion. ► Conducted blue printing sessions for DCM Daewoo, a car manufacturing company in India. ► Implemented a number of enhancements to the MFG/PRO environment at Godrej Soaps, India.Business Applications supported: QAD MFG/PRO 8.5E

Implemented and supported banking software for a number of banks in India.Business Applications supported: Trilogy banking software

Implemented and supported Visesh MRP system in multiple locations. Involved in the package selection, analysis, implementation and post implementation support.Business Applications supported: Visesh MRP system

Maintained Purchase, Financial, Payroll, Income Tax and Provident Fund modules written in MF-COBOL on UNIX. Also developed and customized the Purchase and Inventory modules.Business Applications supported: System developed in house using MF COBOL