PROFESSIONAL SUMMARY:

• 16 years of Life Science Industry Experience with over 12 years of Trackwise experience.
• Implemented numerous validated Trackwise Quality systems with major clients around the US over a 10 years Trackwise consulting career.
• Executed multiple Trackwise systems upgrade implementations.
• Also managed post deployment global support team through Level 3 support for several major Life science companies.

PROFESSIONAL EXPERIENCE:

Confidential, Princeton, NJ

Trackwise Architect

Responsibilities:

• Implementation of a new Load Balnced Test and Prod Application server setup
• Completed the Installation of Trackwie and all of its utilities and components on the new Application Servers
• Implemented two major Enhancement and release cycles to incorporates majot changes to the various modules of Confidential Trackwsie Plaform including Change Control, Complaints, Deviations, Investigations, CAPA’s, Effectiveness Checks, Audits and Observations/Findings

Confidential, Lake Forest, IL

Trackwise Technical Lead

Responsibilities:

• Leading the Technical Implementation of a Major Annual Change Management Cycle for the Global Complaint Management System for all Confidential Global sites.
• Management of all aspect of Project roll out activities including data migration, external system interfaces, user and validation efforts.
• Installation and setup of new Trackwise DEV and QA Instances on new Application servers along with all Integration Manager utilities and interfaces to meet corporate objectives for Load Balancing and System Performance Optimization.

Confidential, Andover, MA

Trackwise System Consultant

Responsibilities:

• Completed the Upgrade of Trackwise version 7.0.5 to version 8.7.2 including the crystal reports, analytics and eMDR module and all Confidential Integration Manager Interfaces already in place including PR Import, Person Import and Entity Import interfaces.
• Management of all aspect of Project roll out activities including data migration, external system interfaces, user and validation efforts.

Confidential, North Wales, PA

Trackwise System Consultant

Responsibilities:

• Led the Technical Implementation of a Global Deviation Report System for all Confidential Global sites.
• Management of all aspect of Project roll out activities including data migration, external system interfaces, user and validation efforts.

Confidential, Vernon Hills, IL

Trackwise System Development Consultant

Responsibilities:

• Engaged in the Configuration validation and deployment of a comprehensive Supplier Quality Management System that consists of projects for management of supply chain, supplier site locations, Audits, Observations, SCAR, risk mitigation, and supplier notice of change
• Delivery of robust system solution based on existing complex business and process requirements using all aspects of the Trackwise WebAdmin, and Trackwise Utilities including all import utilities, Trackwise coordinator and the Audit Execution Package.

Confidential, Richmond, VA

Trackwise System Development Consultant

Responsibilities:

• Installed Trackwise 8.4.4 and all of its associated components, including JDK, Crystal 2008 SP3, Apache Tomcat, WebAdmin, Trackwise Team Access and all integration manager utilities.
• Configured, validated and deployed a CAPA Project/Workflow along with Associated Investigations, Action, Items and Effectiveness checks record.
• Integrated the newly deployed Trackwise platform with SAP and JDE for person, entity and selection import utility services
• Drafted and updated SDLC documents including functional requirement and systems design specs, as well as unit and integration test scripts, and completed traceability matrix on all SDLC documents.
• Managed and completed bug fixes and remediation of erroneous configurations as a result of identified defects during unit and integrations testing efforts in Quality Center.

Confidential, Framingham, MA

Senior Consultant

Responsibilities:

• Managed the Trackwise Infrastructure in conjunction with Corporate Quality Systems Group
• Responsible for installation and deployment of Trackwise and all its associated utilities on new Application Servers, Crystal RAS, and the realignment of App Server and DB Server across all Validated and Non Validated Trackwise Environments
• Responsible for the execution of Migration of major Trackwise Release cycles across multiple validated environments
• Responsible for execution of table top and functional Disaster Recovery exercises on the Trackwise platform.

Confidential, Fort Worth, TX

Senior Information System Specialist

Responsibilities:

• Managed all aspects of the Confidential Trackwise Program including new system development, routine and major system enhancements to Confidential Global Product Complaint Management System as well as project management, system configuration/development, testing/validation, user and system deployment.
• Developed all pertinent documentation in support of changes to the validated Trackwise system including Functional and Design specification as well as implementer/user acceptance test protocol and change implementation plan
• Developed detailed implementation and execution plan for all new Trackwise initiatives and manage execution of projects via the coordination of activities across a multifunctional project delivery team.
• Managed and executed all aspects of the Global upgrade project to transition the Trackwise platform from version TW 6.0 to TW 8.3, this includes preparation and execution of the Project Implementation Plan, IQ, OQ and PQ, actual system upgrade and integration with other systems, and user .

Confidential, Andover, MA

Consultant - Trackwise System Configuration Team Lead

Responsibilities:

• Led a team of 4 other Trackwise System administrators in the conceptual development, design, validation and deployment of a Trackwise system for the management of Confidential Global CAPA and Investigation Program
• Development of all technical documentations in support of Trackwise system deployment including Functional Specifications, Design Specifications, Trace Matrix and validation protocol
• Coordination of all necessary technical team support with respect to system integration testing/user acceptance testing initiatives, and end user strategies.

Confidential, Wauwatosa, WI

Consultant - Trackwise System Product Support Team Lead

Responsibilities:

• Led Configuration efforts for the deployment of Trackwise systems for Adverse Events Report Management, Complaints Handling System, Investigation System and CAPA System.
• Led a team of 8 other Trackwise System administrators in the provision of pre and post deployment configuration and user administration support to Confidential healthcare global operations across 7 Divisions in North America, Europe and Asia and involving approximately 16,000 Trackwise users.
• Provision of strategies for utilizing Trackwise utilities including PR imports, Person Imports and Selection Imports to accomplish the integration of existing records, users and data from other legacy systems into Trackwise
• Developed and executed plans for the day to day provision of 24 Hours support to all Trackwise users around the globe by members of my Global Product Support team.

Confidential, San Francisco, CA

Consultant Trackwise System

Responsibilities:

• Developed, designed and configured Trackwise system for Confidential Drug Safety group for the management of all Adverse Events, their subsequent investigations and corrective and preventive actions (CAPA).
• Developed, designed and configured Trackwise based system for Confidential Drug Safety for the management of regulatory agency Audits, observations and CAPA.
• Provided design and configuration support on other management and enhancement projects for Confidential Product Complaints Systems for the management of complaints and Investigations.
• Routinely held close consultation sessions with business group to determine exact business rules and requirements for the processes being designed, and proffered technical solutions to all identified process bottlenecks with to each system.
• Drafted and finalized various technical validation documentations in support of the system build including Functional Specifications, Design Specifications, Configuration and Systems Verification documentations and Systems Unit test documentations.

Confidential, Coppell, TX

Quality Information Systems Manager

Responsibilities:

• Developed, implemented, and administered various Trackwise 6.0 (SR 43) based quality management systems including: change control, quality complaints, internal/supplier audits, deviations, investigations, non-conformances, adverse events reporting and corrective and preventative action (CAPA) systems; resulting in a $500K in cost savings of out of specification products and product recalls in 2006.
• Lead various activities geared towards executing various modules of Trackwise system including analyzing and documenting company requirements, installing the Trackwise software; configuring the software to implement Confidential business requirements; validating the system and of Trackwise end-users.
• Completed on going migration of existing quality data from various ERP systems into Trackwise.
• Designed crystal reports for various business purposes capturing key quality and regulatory required information.
• Routinely implemented system updates to existing Trackwise configuration leveraging all modules of Trackwise including Administrator, Coordinator, Migrator, and Integration Manager
• Prepared detailed product quality summary sections for product license applications to various global regulatory agencies in support of commercialization of new Confidential products, reducing regulatory approval time for products from more than 15 months to less than 6 months

Confidential, St. Louis, MO

Regulatory Assurance Manager

Responsibilities:

• Managed timely preparation and submission of all reports, registrations, fees, and other documentation; ensured compliance with regulatory requirements/ corporate procedures.
• Evaluated/interpreted regulatory requirements and assessed corporate alternatives; achieved 100% level of regulatory compliance pursuant to external audits by FDA.
• Reviewed new project proposals; conducted background research on drugs and labeling to determine accuracy/completeness of project information, required strategy for regulatory approval, and special regulatory considerations.