SUMMARY:

• Seasoned leader and highly skilled professional, with diversified experience across information technology operations spanning strategic planning, management and change management; application, database, and systems development and delivery; business systems analysis; and software development life cycle (SDLC) management.
• 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 inspire 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. Inspire, create, teach, mentor, and lead teams to further the needs of the enterprise.

AREAS OF EXPERTISE:

• Problem Identification and Resolution 
• Teaching and Coaching 
• Continuous Process Improvement
• Enterprise Resource Planning (ERP) System Management
• Oracle Applications Support
• Regulatory Compliance
• Resource Management, Confidential (QMS)
• 21 CFR Part 11
• Business Domains (Clinical, Regulatory, Manufacturing, Finance, Quality Assurance, and Human Resources)

Confidential, Malvern, PA

Director of Enterprise Information 

Responsiblities:

• Strategic planning, change management, process improvement initiatives.
• Build Enterprise Information Systems group - Business Analysts, DBA, and Development team from ground floor.
• Creation of Data Governance and Master Data Management plans and process.
• Selection and implementation of iPaaS / Enterprise Service Bus (ESB).
• Change leader and multi-department facilitator of ideas and problem solving.
• Oversee the development of Oracle E-Business Suite instances application, daily functions of DBA Team, and implementation of a new module.
• Serve as project manager for all Oracle upgrades, from 11.5.9 to 12.1.3, including organizational project management (OPM) to core migration and mapping for Oracle EBS R12.
• Guarantee the provision of application support to user community in the areas of ASC, OPM, financials, human resource management system (HRMS), and quality assurance.
• Display solid leadership and technical skills in overseeing application development for in-house quality process application and corporate database servers design and implementation.
• Observe strict adherence to software development life cycle (SDLC) procedures in creating user requirements for new enterprise applications.
• Earned selection from the senior leadership to build a Business Application Development and Support Team to address IT needs of a growing manufacturing company.
• Developed and managed the Electronic Initiative Committee, which comprised of cross-functional professionals tasked to oversee application development and new software and technology integration toward the improvement of quality, manufacturing, financial, and supply chain processes.

Confidential

Project Manager, Technical and Design Lead

• Formulate data migration and application migration plan from Oracle documentation, which involve mapping of data migration from Oracle 11.5.9 OPM to Oracle Core inventory.
• Effectively function as part of the first OPM inventory migration efforts, including direct communication with Oracle OPM Migration Team in Boston.
• Partner with Oracle DBA in debugging issues, identifying patches, and migrating and patching scripts.
• Created PL/SQL code to resolve costing issues, including conversion to new cost methods and calendar setup.
• Utilize .NET in developing check printing solution and custom code to bypass Oracle Payables feature lost in R12 module.
• Conduct manufacturing resource planning (MRP) patch analysis to ensure alignment with analyst, DBA, and implementation requirements.

Confidential

Lead Application and Database Analyst/Designer/Developer

• 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.
• Took accountability in developing VB.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 Confidential .
• Made use of pessimistic database connection model and database development design that brought reduction in down-time, application errors, development time, and validation efforts.

Confidential

Project Manager

• 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 methodology (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.

Confidential

Requirements Gathering, Selection, Implementation, Data Migration/Qualification

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

Confidential

Requirements Gathering, Selection, Implementation, Data Migration/Qualification

• Participate on team to create user requirements and evaluate vendors for purchase of CAPA system.
• Develop reports and analytics for Confidential .
• Lead technical analyst and DBA to implement Trackwise - includes role in 2 major version upgrades.
• Participate in global roll-out of CAPA to parent company.

Confidential

Strategic Direction, Technical Support

• Identify solutions and develop Functional Design Specifications for analyzer to LIMS automation solution
• Diagnostic test analyzer platform to LabVantage bi-lateral data transfer solution
• Manage team to design Freezer monitoring network based on a PLC based methodology and WonderWare historian/LIMS database.
• Develop reporting for auditing, data verification and validation for all equipment calibration and monitoring applications.

Confidential, Douglassville, PA

DBA, Owner, Business Analyst, Designer, Integrator, and Developer

• 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.
• Performed Oracle E-Business migration, from 11.5.3 to 11.5.9 and 11.5.9 to R12; as well as SAP data migration mappings from multiple legacy systems.
• Oversaw remote DBA, developer, and outside resources involved in the Oracle EBS configuration and customization.
• Participated in rewriting batch records for production and standard operating procedures (SOPs) for IT practices spanning disaster recovery, good manufacturing practices (GMP) packs, and SDLC.
• Steered efforts in integrating applications in various areas of the company, which involved manufacturing, quality assurance (QA), quality control (QC), regulatory affairs, customer service, and clinical affairs.
• Led the software selection teams in choosing software for Manufacturing, Quality Assurance, and CA departments, as well as to design data migration plan.
• 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 off-the-shelf systems in accordance with user requirements.
• Piloted the integration of first PLC-based equipment monitoring system for a medical device company.
• Concentrated on improving operational performance by building and managing the following groups:
• IT Business Application Development Team responsible for configuration, process improvement, and support of enterprise and global business applications and all Oracle and MS SQL databases
• IT Department for new acquisition in charge of enterprise and global application selection, development and implementation
• Electronic Initiative Committee accountable for the analysis of overall processes to minimize paper and redundant tasks, as well as to improve quality

Confidential

Lead analyst | Manager

• Create the IT Department for the new company.
• Lead the selection process for other technical functions for the replacement of legacy ERP systems.
• Supervise and guide one full-time employee and remote Oracle DBA group, supporting Oracle applications and batch record application, along with in-house software development and Oracle and MS SQL database administration and development.

Confidential 

Manager, Analyst, Lead Application and Database Analyst/Designer/Developer

• Leveraged expertise in designing and developing in-house batch record and document management system for a world leader cancer testing, involving development of B.NET, Crystal Reports, and Oracle PL/SQL.
• Initiated application design using object-oriented design/programming which contained stored procedures that served as application program interface (API) for developers in other areas of the company as well as direct integration with Oracle EBS OPM Inventory.
• Developed Document Management functionality for controlled SOP’s, Specifications, Labels and Batch Records.
• Brought significant reduction in down time, application errors, and development time through the utilization of pessimistic DB connection model and DB development design.
• Write supporting validation documents (traceability matrix and functional design) and reports for validation team.
• Provide strategic leadership, planning and application selection for Lab connectivity projects, LIMS integration, ELN requirements, CQMS and QMS.