Quality Manager for all systems and organizational operations. Hired as an expert GxP / quality consultant in order for the organization to revamp processes on new and expanding systems. Driving quality changes by assuring all personnel adhere to the revised policies and procedures. Setup companywide wireframe to plan and execute procedural changes

Self employed professional DJ for over a decade. Performed events all over the east coast, from Boston to Atlanta. Club DJ in Dominican Republic and Brisbane, Australia. Private events, clubs, corporate events, etc.Also host of a weekly global radio show called the Centrifugal Force Owner of Neos Imperalis records.

Software QA Lead for all systems companywide. Managed several teams and contractors during validation activities for systems being updated and implemented. Provided project status and challenges to management and reported directly to the executive team. Assisted QA team with SOP and process improvement as well as assisting with internal and external audits. Established a multi departmental effort to implement a 21 CFR part 11 compliance process, and drove this effort successfully for several major software releases.

Served as Validation lead for all activities for the Talix and Eureka Pipelines for a cancer clinical trials system. Ran daily status meetings with a US and India based team, gathered system requirements from several departments, OQ/PQ and IQ test case authoring, review and analysis of testing evidence, design documentation creation, testing deviation reporting and tracking, CAPA creation, tracking and closure.Handled validation training with various client members to familiarize them with good documentation practices both onshore and offshore. Managed all testing documentation for project summarization and closure including validation summary reports, CAPA reports, release notes, and disaster recovery plans.

Spearheaded all validation activities for the MMIT (Managed Markets IT) department and other related sub-projects as well as continuous process improvement, SOP revisions, and other corporate compliance administrative activities. Oversaw validation activities for the Government Pricing and Medicaid work streams for a major software implementation project (2012 -2013). Including Pre/Post-execution Test Case Approvals, System/User Acceptance Testing documentation authoring and approval (Test Specification Reports, Test Summary Reports, Requirements Gathering and Coverage, Defect Reporting/Criticality), Compliance weekly summary reporting (metrics of test cases execution, defect authoring, reporting and tracking). Created corporate procedures that outlined and streamlined testing activities and established guidelines for use during Phase 2 (Testing Process, Error Reporting, Training, etc.). Crafted crucial documentation outlining data flow and compliance strategies to provide for internal and external audits. Performed administrative compliance activities regarding production file migrations and SQL code deployment for over 100 corporate-wide software upgrades spanning 2 years. Spearheaded recovery activities and the reassessment of all corporate security documentation following a global cyber incident, revising 35+ corporate SOPs to include additional security procedures.

Subject matter expert to assist with validation efforts for a major internal system implementation. Handled various corporate quality documentation revisions, requirements gathering and risk assessment activities. Re assessed and streamlined testing strategies to be utilized for future software upgrades.

Served as validation Lead for the implementation of a global records management system, Central Index of Company Records (CICR).Created and executed functional, user acceptance, and performance qualification test cases. Managed SDLC documentation, liaised with corporate compliance team for all project deliverables, and assisted corporate compliance with an internal audit of all testing activities regarding the CICR project. The results of the internal corporate audit returned 0 CAPA findings.

QA Lead for Medicaid & GP work streams

• Participated in requirements gathering activities to design software systems developed for in house use throughout the Global organization • SHARE • Legacy Records • Product Submission Folders• Worked closely with end business users to gather requirements• Authored system test scripts based on functional requirements specifications • Managed investigation and testing activities to correct several critical updates required for a global system dealing directly with the FDA• Handled multi-organization license management for several software platforms

First job after graduating from Penn State. On site at numerous major pharmaceutical companies supporting software testing. Learned how to gather requirements, draft effective test cases, handle client requests, and write compliant project documentation. Managed an internal SQL administrator position that handled multiple pharmaceutical clients simultaneously while delivering ad hoc updates to corporate labeling documentation. Met with various FDA regulatory personnel to support the SQL administrator efforts as well as other high level pharmaceutical end users to gather information about system needs. Supported internal corporate quality assurance for all systems and projects.