Senior-Level Management / Business Systems Leadership / IT Governance

Mission Statement: Inspire, create, teach, mentor, and lead teams to further the needs of the enterprise.

Demonstrate expertise in developing and leading top-performing teams to align work performance with business needs and requirements. Excel at managing and directing teams and departments to motivate use of in-depth knowledge of cutting-edge tools and methodologies, while adhering to industry standards and best practices. Possess outstanding ability to create and integrate technical solutions to drive operational efficiency and productivity. Exemplify effectiveness in collaborating with other professionals, coupled with capability to adapt to and function well within critical and fast-changing environment.

Areas of Expertise

CIO Level Decisions Program Development Leadership Development Department Building Teaching and Coaching Continuous Process Improvement Enterprise Resource Planning (ERP) Leadership Oracle Applications SAP Regulatory Compliance Resource Management Quality Management Systems (QMS) 21 CFR Part 11 DG & MDM iPaaS & ESB Data Domains Business Domains (Clinical, Regulatory, MFG, Finance, Quality, and Human Resources) Infrastructure Security Policies SDLC FDA Compliance SOX, JSOX Governance Infrastructure Business Alignment Budgeting

Relevant Experience

1991 – 2010, 2018 - Present Absolute Integration, Inc. / Douglassville, PA and Davidson, NC

Founder, Owner, Integrator

Create consulting / development company with business development and customer acquisition responsibilities.

Data pipeline: data governance, MDM, data warehouse, ETL, database architecture, analysis, iPaaS, quality, cleaning

Lead projects for Manufacturing, Engineering, FDA and Regulatory Compliant customers.

Design automated data capture and transformation design and methods for Medical Device Equipment.

Custom application development in different industries: Engineering, CRO, Medical Device, Pharma, Financial, Education, Construction, Chemical, Petrochemical, Paper, Insurance, Legal.

Custom database planning, design, modeling and architecture (PL/SQL and T-SQL)

Creation of a new IT department for new division starting with no in-house IT personnel: hired managers, managed network and server installation teams, installed ERP, QMS, and MS Office systems.

Directed the operation of a software development and integration company, with specialization in manufacturing and financial applications, including Microsoft SQL and Oracle DB consulting services.

ERP migrations and implementations.

Oracle EBS enhancements through built in functionality: Customer Concurrent Manager functions, PL/SQL, and FF.

Enterprise Service Bus (ESB) and data warehouse integration.

SAP data migration mappings from multiple legacy systems.

Oversee remote DBA, developer, and outside resources involved in ERP configuration and customization.

Lead initiative to rewrite standard operating procedures (SOPs) for IT practices spanning disaster recovery, good manufacturing practices (GMP) packs, and SDLC.

Steered efforts to integrate applications in various areas of customer applications: manufacturing, quality assurance (QA), quality control (QC), regulatory affairs, customer service, and clinical affairs.

Led the software selection teams to choose software for Manufacturing, Quality Assurance, and Clinical/Regulatory departments; lead the design of data migration plans.

Executed design and implementation of Oracle and MS SQL hot backup methodology; database cloning procedures between validated application instances; and database backup and recovery testing for GMP.

Created and instituted data model for database-centric applications in Oracle 9i, 10g, 11g, and MS SQL.

Expertly used integration services in automating the importation of data from external applications for report development.

Collaborated with various companies in designing in-house applications and purchasing COTS in accordance with user requirements.

Piloted the integration of first PLC-based equipment monitoring system for a medical device company.

Data Analytics and analysis for MFG, Engineering, and Construction

2010 – 2018 Fujirebio Diagnostics, Inc. / Malvern, PA

Director, Enterprise Information Systems (2016 to present)

Strategic planning, change management, process improvement initiatives.

Develop budgets for yearly IT projects including FTEs, contracted resources, licensing, new initiatives.

Contract negotiations and process evaluation with savings of over $1 million.

POMS implementation team and lead integration design and architecture.

Responsible for IT project presentations and approvals to executives from parent company in Japan

C-level presentations and approvals

Creation of Data Governance (DG) and Master Data Management plans and process.

Business taxonomy definition and classification of organization, data, and components of DG.

Partnering with cloud solutions and providers – iPaaS, Applications (ELN, SFDC, storage…).

Selection and implementation of iPaaS / Enterprise Service Bus (ESB).

Change leader and multi-department facilitator of ideas and problem solving.

Enhance department to support needs of organization by Creating new roles for a Manager of Business Systems, QMS analyst, Scientific Systems Analyst, Master Data Management Analyst, iPaaS/ESB team.

Removal of custom and one-off applications by utilizing and leveraging existing ERP, QMS and Clinical functionality.

Data analysis, reporting and enterprise visibility as part of centralized data store and federated/virtualized model.

Implementation of VM technology for Upgrades, Compliance, Testing, DR, Application and Database Cloning

Earned selection from the senior leadership to build a Business Application Development and Support Team to address IT needs of a growing manufacturing company.

Build Enterprise Information Systems group from the ground floor: Business Analysts, DBA, and Developers.

Manage development of Oracle E-Business Suite, user support, daily functions of DBA Team, and implementation of a new functionality and modules: ASC, OPM, BOM, Financials, HRMS, Endeca, Supply Chain, OM.

Serve as project manager for all ERP implementation and upgrades.

Strict adherence to SDLC procedures in creating user requirements for new enterprise applications.

Build foundational components of IT and Data Governance by assessing IT resources, talent, and gaps analysis.

Lead and participate in application design, database design, and custom development projects to coordinate with COTS integration and extensions for enhancements.

Develop training programs and foundational components.

Significant Projects and Career Milestones

Data Domains / Data Science

iPaaS ESB with API first microservices approach between Salesforce.com, CRM, ERP, QMS and MES.

Justify, evaluate, select and implement first iPaaS solution in global chain (MuleSoft).

ESB integration between Salesforce.com CRM, ERP, and custom application utilizing IBM Cast Iron.

Non-invasive Data Governance and Master Data Management enforcement, taxonomy, and initiatives.

Data Warehouse and Data Lake - Custom data store for centralized reporting model.

Developing a coordinated effort in the organization to recognize and commit to a DG program.

Pivot tables, charting and analysis in different tools (MS Excel, Crystal, PowerBI, and others).

Application Design and Development

Design, develop interfaces with multiple ERP systems using APIs, data layers, and customer services/packages

Design, Develop custom (application independent) reporting system: web layer, configuration tools, data layer

Design, develop custom applications different industries: engineering, process MFG, finance, service, biotech

Building IT / Mergers / Governance

Centocor Diagnostics sale to Fujirebio Diagnostics, Inc. (FDI) – Build new IT Department

oHired as consultant after sale of diagnostics division to FDI with no IT department or personnel

oDirectly responsible to hire IT Director – worked together to build new department

oDesign roadmap to build data center, MS Office applications, servers, network, desktops, Backup/DR

oDesign roadmap to build business solutions platforms: ERP, QMS, Bath Record System, CAPA

oDesign roadmap to validate systems`

oAssist director to add IT personnel and outside resources

oConvert data from parent company: Financial, Manufacturing, Inventory, Batch Records, Documents

oBuild ALL systems, implement ALL applications, convert data - 5 months from start to finish

oContinue to support new IT organization and stay on as application, database, and development resource

oLead or participate in the development of supporting programs: SDLC, Validation, Source Control

FDI - Build New IT Enterprise Information Systems Department

oHired to build applications, data and development group: BAs, DBAs, Developers, Governance, QMS, LIMS

oDesigned roadmap, organization charts, wrote job descriptions, recruited, interviewed and hired talent

oStrategic planning to serve business that grew experiencing intense level of growth

oStrategic planning including in-house talent, outsourced partnerships, applications, data, infrastructure, DR

oImplement all hiring and talent acquisition, governances, and applications

oLead initiatives to identify and justify new systems: ERP, CAPA, PLC/Historian, EDMS, MES/eBRS, DG, MDM

oParticipate as team member or lead in each system identified

Centocor Pharma sale to Johnson & Johnson

oParticipate in merger data and application projects: HR, Finance, Inventory

KSG Industries Reorganization

oAssist in KSG Global Organization and consolidation of ERP systems: Financial, Inventory, Supply Chain

Elf Atochem and TotalFinalElf merger to form Atofina / 2004 Atofina to Arkema Global Reorganization

oParticipate in Global application - data migrations to single Incident Tracking & CAPA management systems

oParticipate in Global MS Office conversions and upgrades

oParticipate in Global data migration of home-grown ITM and CAPA to Global Systems

ERP (Business Systems)

Project Manager, Technical and Design Lead.

Implementation, integration, custom development, migration and upgrades for numerous ERP systems including MCBA, Exact Max, Macola, SAP, MS Dynamics, and Oracle EBS.

Formulate data migration and application migration plan from vendor documentation to map of data migration.

Partner with DBAs and Functional Analysts in debugging issues, identifying patches, and migrating and patching.

Develop and configure modules in Financial, BOM, Routers, Batches, OPM, OM, Receivables, Payables, GL, HR.

Created T-SQL and PL/SQL code to resolve functionality gaps and work-arounds for custom solutions.

Utilize .NET in developing new code to bridge functionality gaps and work-arounds for custom solutions.

Conduct manufacturing resource planning (MRP), Supply Chain and Financial module analysis to ensure alignment with analyst, DBA, and implementation and business requirements.

Banking automation: NACHA, positive pay, workflow approvals, Sarbanes-Oxley, Affordable Care Act

MES and Batch Record

Exemplify strong technical competency in designing and developing in-house batch record application.

Render keen oversight to the Implementation Team in carrying out validation and data migration verification, along with documentation and qualification for Food and Drug Administration (FDA) validation.

Lead Application and Database Analyst/Developers in development of .NET, Crystal Reports, and Oracle PL/SQL.

Employ solid knowledge of object-oriented design and programming in creating the application to interface with Oracle Applications OPM tables.

Integrate data batch records lot numbers, expiration dates and customers with Trackwise CAPA.

Made use of pessimistic database connection model and database development design that brought reduction in down-time, application errors, development time, and validation efforts.

Develop requirements, justification and ROI for MES and eBRS.

Successfully present first MES and eBRS in the global structure to global executive committee for approval.

Lead selection team to evaluate and choose MES and eBRS solution. Present methods to Global IT group in Japan.

POMS Implementation team lead for IT, databases, and ERPi integration.

Lead team to evaluate and select first PLC based data collection network and WonderWare solution.

QMS, LIMS and Regulatory

EDMS / Customer Developed and MasterControl

Recruited cross-functional team and led a committee in charge of creating justification and user requirements for EDMS evaluation.

Executed wide-ranging research to identify appropriate vendor to meet EDMS requirements, including negotiation of terms, contract, and agreements.

Devised and implemented comprehensive project plan in collaboration with internal project team and vendor project team.

Develop procedures to move data from 3 instance methodologies (development, validation and production).

Design routes, workflows and approvals.

Design data mapping to build document library vault.

Designed and developed previous in-house Document Management solution tied to in-house batch record system.

LIMS/ELN System

Requirements Gathering, Selection, Implementation, Data Migration/Qualification.

Collaborate with Clinical Affairs department to create User Requirements for Biobanking, Sample Management and EDC LIMS system.

Analyze, debug, and resolve issues in LabVantage LIMS Biobanking, Sample Management, and Studies.

Lead LabVantage 8 assessment, installation and data migration for upgrade from LV6

Create Functional Requirements for Sample Management and EDC LIMS system.

Key stakeholder for selection and implementation of Freezerworks (Dataworks) LIMS Biobanking software.

Key stakeholder for selection and implementation of LabVantage EDC LIMS.

Lead technical analyst for data importing into Biobanking, Sample Management and EDC LIMS.

Participated in validation efforts in all phases of IQ, OQ and PQ.

Developed queries and reports for LIMS analytics and data verification.

Write and conduct vendor audit to qualify Freezerworks/Dataworks.

Participated in vendor audit to qualify LabVantage.

Performed interviews and participated on selection team to choose LabVantage integrator.

Developed algorithm for key business requirements including aliquoting, freeze-thaw cycles and sample-centric design to fit user needs.

Lead team to evaluate and select Electronic Lab Notebook (ELN) solution.

Technical Acumen

Oracle PL/SQL and SQL*Plus

Oracle 9i, 10g, 11g, 12c

Oracle DB Utilities: sqlplus, TOAD, Oracle SQL Developer, PL/SQL Development

Microsoft Transact-SQL

Microsoft SQL 2000, 2005, 2008, 2012, 2016

SSRS, SSIS, Power BI

Crystal Reports

MS Access

Spreadsheet Server

VB and ASP .NET 2005, 2008, 2010

Windows Scripting

Linux Shell Scripting

MuleSoft Anypoint Studio and Management

JASON, XML, REST

Java scripting

VBA scripting

Full tier development experience – Presentation, Application, Business Rules, Data Layers

Education and Training

Master of Arts in Organizational Leadership

Alvernia University, Reading, PA

Bachelor of Science in Computer Science

West Chester University of PA

Emphasis in development, algorithms, and mathematics

Minor in Earth Science

Professional Development

CIMP Training for Master Data Management and Data Governance

In-House Management Training Series: 2012 to present

MasterControl EDMS Document Essentials: 2015

Oracle University – Oracle E-Business R12 Administration: 2012 Oracle DBA: 2004

National Premier Soccer League (NPSL) – Semi-Pro Soccer Reserve Training: 2013

National Soccer Coaches Association of America (NSCAA) Coaching Certifications

United States Soccer Federation (USSF) Coaching Certifications

Other Experiences

Coaching, Training, Teaching, Mentoring – 1988 to Present

Ada Jenkins volunteer food pantry, tutoring, food delivery

Feed NC / Mooresville Soup Kitchen – food pantry, kitchen staff, food pickup

Big Brothers / Big Sisters

Urban Ministry programs for inner-city outreach

The Outreach Program for Soccer – program for Children with special needs

College Soccer Men’s Assistant Coach

High School, Club and Player Development Coach

High School Music program instructor

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