Summary

• A proven leader with a successful track record of completing challenging projects while exceeding performance objectives in a wide variety of business applications in pharmaceutical and other industries.
• Successfully managed global projects across multiple stakeholders demonstrating effective management of people, technology, innovation, and process improvement in both regulated and non-regulated environments.
• Provided effective, customer-focused solutions mapped to corporate objectives and strategy using strong interpersonal, communication and negotiation skills.
• Proven ability to manage the full IT Program/Project Development Lifecycle SDLC , RFP Management software and services , Contract Negotiation, Project Planning and execution, Computer System Validation, Projects involving Custom Development and Package Configuration, Relationship Management. Partner with key stakeholders to effectively plan and execute strategic enterprise-level business initiatives.

Project Management Vendor Management

Systems Integration Strategic Analysis

Systems Development Life Cycle Technical Documentation

Compliance Validation

Professional Experience

Consultant

• Project Manager Consultant at Maquet Medical Device Company
• Project manager Track Wise global system installation and upgrade for CAPA, Complaints, UDI, SCAPA and eMDR.
• Assisted in the management of the upgrade and implementation of a new TrackWise system. Participate and manage all phases of the project including reviews, vendor management, requirements gathering, testing while following project management tools for System Development Life Cycle SDLC .

Consultant

Project Manager

• Manage archiving and decommission global projects utilizing SAP Data Archiving, OpenText Imaging and DaRT. Develop strategies and educate client's team about SAP Archiving implementation processes.
• Deliverables are based on retention management strategies and regulatory compliance. Participate and manage all phases of the projects scoping, proposals including statement of work, project planning, testing and delivery while following project management tools for System Development Life Cycle SDLC .
• Program / Project Manager Consultant at Novartis pharmaceutical
• Program manager Novartis Enterprise Web Services. Global integration SharePoint.

Confidential

Program / Project Manager

Worked with several different business groups and led a variety of projects from small initiatives to complex global projects. Initiated projects, monitored and communicated, status and risks to all participants including IT, business and outside resources and vendors. Utilized Clarity to control, monitor and report on all projects.Managed and participated in computer systems validation, GMP and 21 CFR Part 11 assessments. Was responsible for the creation and execution of validation documents for system changes. Developed validation protocols and assisted in the creation of validation scripts, testing and completion of the validation plans for compliance and GxP systems.

Roles and Responsibilities

• Managed implementation of several new product launches across multiple systems in the global Supply Chain organization. Managed a matrix organization to successful project completion ahead of schedule.
• Utilized TrackWise to manage Change Control, Risk Management, Batch Record / Batch Release
• Tracking and Audit Management.
• Overall IT project manager for the Global Supply Chain in the consolidation of Schering Plough U.S. data centers
• Overall Global Supply Chain IT project manager for the retirement and decommission of global systems. Exceeded savings goal by 60 .
• Overall Global Supply Chain IT project manager for the integration of Schering Plough and
• Organon. This included business processes and systems for Customer and Marketing Services, Logistics/ Distribution, Inventory Planning and Management, Warehouse management, Customer Returns, Material/ Cost Accounting and the Financial A/R functions associated with SAP Order to Cash system.
• Managed SAP Advanced Planner and Optimizer SAP APO Blue print project for Schering Plough Supply Chain group.
• Implemented and managed Capacity Planning SAP BW global system for packaging and manufacturing data from 20 locations. Applied all aspects of full system life cycle development and change management.
• Managed the following applications for the Logistics organization and acted as a liaison between the business units, IT, internal and external vendors.
• CSS Customer Service System is the trade order system for Schering Plough integrated with WMS.
• Customer Service imaging system, captures all images relate to customer orders.
• SLA/SLC is the samples and literature order system for Schering Plough.
• In two phases of document management replacement, managed the data migration of over 500k documents from a standalone WaterMark FileNet document system to an IXOS Doculink document system.
• Proposed and designed the replacement system, presented to the steering committee, created RFP and proposed the IXOS system selection that was fully integrated with SAP modules.
• The system was composed of scanning solution, barcode creation and document archiving. Conducted GxP assessments and produced all required documentation and SOP's in coordination with the validation and QA departments.
• Managed the implementation of the IXOS document management system and as a hands-on manager assisted with the technical solutions and testing of the new system. Managed a master project plan, risks, change control process, conducted all meetings and reported status to senior management.
• Coordinated the vendor's implementation phases and managed and coordinated the post implementation support.
• Created training materials for the scan operators and business users and trained over 100 users in the different departments. Became the SME for the document system and assisted other global groups with their system implementation.
• Managed all stages of business requirements gathering, testing, validation and deployment of application changes. Additional responsibilities included the creation of RFPs, envisioning documents, summary documents and other systems supporting documents.
• Researched, proposed and negotiated a replacement of the Denied Party system with the regulatory department to a fully integrated SAP module and negotiated a 3rd party software solution to collect the government data.
• Managed and implemented the Denied Party Screening System for legal compliance.
• These regulatory system checks entities that are prohibited from conducting business with US Pharma companies based on the government listings.
• Became the SME on this system and assisted multiple locations around the globe.
• Assisted with the implementation of the regulatory system during the integration of Schering Plough and Organon.

Confidential

Manager Software Development

• Managed three teams of consultants and full time employees in the development and maintenance of software applications.
• Managed all stages of testing/integration testing, QA and deployment of applications in a global environment.
• Managed a client server reporting application utilizing GUI presentation, Media and COGNOS Impromptu reporting tools.
• Managed a data repository with GUI presentation and web-enabled global application.
• Managed a global table driven system to collect all financial data premium and losses and create corporate history repository for reporting purposes.

Confidential

Project Manager

• Managed two teams of consultants and full time employees in the development and maintenance of two applications. Managed the full life cycle of conversion to DB2 including extensive testing and QA.
• Sales Practices Oversight and Control SPOC is a compliance client server application. Managed integrated testing and Model office testing of the application to validate clean integration with other application on agent's laptops.
• Agency database is an application to store and monitor insurance agent's indicative data. The data from this system is used in a broad spectrum of other applications within Prudential. Managed the certification and testing of the system for Y2K.

Confidential

Project Manager

• Leading conversions, interfaces testing, QA and development of Employee Access Accounts and GlobalBuilder with an overall budget of 1M.
• Managed the data navigation and storage group for a new development of Integration Benefit services, Defined Benefits system.
• The system was designed as three tier architecture with DB2 tables, Sun UNIX server utilizing Oracle and NT platform. Conducted JAD sessions, participated in the business requirements, data modeling, logical and physical design.
• Managed a team of programmers in converting and developing new 401k plans. Designed and developed interfaces, conversion plans, programs, and system changes for seamless EAA systems conversions and 401 k payroll conversions. Directed communication/testing/validation QA with clients and programming team during all phases of conversion. Conducted client presentations in order to get correct information from payroll providers.
• Managerial duties included project planning, extensive testing of conversion and interfaces, data validation QA of payroll and conversion information, developing cost/benefit analysis, conducting performance/salary reviews, evaluating software packages and recommending system solutions.

Confidential

Project Manager

• Led the conversion and development of 401 k systems for new and existing fortune 1000 clients.
• Managed a team of programmers in the design and development of conversion plans, programs/testing/validation plans, interfaces and system changes for seamless 401 k systems conversions.
• Directed communication with clients and programming team during all phases of conversion.
• Conducted client presentations and post conversion meetings in order to get correct information from former record keepers and payroll providers.
• Managerial duties included project planning, extensive testing of conversions and payroll interfaces, data validation QA of payroll and conversion information, developing cost/benefit analysis, screening and hiring of new employees, and conducting performance/salary reviews, evaluating software packages and recommending system solutions.

Confidential

Technical Manager/Senior Systems Engineer Consultant

• Performed analysis, design, programming and implementation of systems for financial institutions and telephone companies. Assisted with recruiting and sales for various consulting positions.
• Technical Manager and Recruiter. Duties included conducting technical interviews, annual salary and performance reviews for twelve consultants.

Confidential

Consultant/Senior Programmer Analyst

• Performed Analysis, design, programming and implementation of clinical systems and conversion systems for marketing department.
• Responsible for the conversion of the account payable system for a division of Ford Motor Company.