Business Solutions Analyst

Posted on: 2006-01-02

Telephone: 973-998-0676 E-mail: [email protected] Mobile: 973-879-6595 BUSINESS SOLUTIONS ARCHITECT FOR QUALITY AND REGULATORY AFFAIRS Proactively Increasing Profits By Creatively Solving Profit Draining Problems * Maintained knowledge and report upward on new developments in the market place, especially with regard to accounts and prospects. * Leadership - Built risk registers for senior management on the opportunity (qualifying pursuit). * Built external partnership agreements for significant accounts. * Team Building - Actively developed customer relationships in support of account and opportunity strategies. * Built the internal relevant teams. * Business Process Mapping * Bid-Management Process in developing proposals that articulate the clients\' needs. * Hands-on Validation (IQ, OQ, PQ) * Compliance - FDA, GxP, Pharmaceuticals, Medical Devices, Lab Practices, SOX, ISO, Six Sigma * Recruiting * Audit and Tracking/Reporting * Exception Management, Process Excellence, Investigations and Solutions Management * PMI * Risk, Design, Control, Assessment * Employee Training/Coaching and Relationship Building Strategic Planning Leadership Team Building Business Process Mapping Regulatory Compliance Quality Assurance Release Management Relationship Management Validation Audit, Tracking, Reporting Risk Design and Control Training and Mentoring STRATEGIC * Highly skilled and experienced negotiator able to quickly build effective relationships, with senior, key influential external decision makers, i.e. Directors, Business Unit Heads, HR Directors and Finance Directors. * Several records of achieving sales plans that result in major business * Good communication and presentation skills. * Innovative/Creative approach to drive commercial benefits for both client and products/services * Firm Grasp of technology and technical solutions * Decision Maker * In-Depth Understanding of all Opportunities and P&L * Contract Negotiation skills * Built partners based on the transformational opportunity * Built propositions * Program Management Leader * Excellent Decision Maker KEY MANAGEMENT STRENGTHS Developed, executed and supported IT planning and operations for company in US Corporate and Overseas branches of international offices. Full accountability for the entire SDLC integration required to process global transactions. Formulated global relationships, preformed risk assessments against planned milestones, managed SOP documentation, and oversaw base operations. RESULT: Robust products were rolled out on time and within budget. Tasked by CEO of rapidly growing software development firm to turn around \"bug-plagued\" product line. Led initiative to reengineer software development life cycle processes to improve quality. Built new IT Research and Development and Validation (IQ, OQ, and PQ) departments compliant with Capability Maturity Model (CMM) standards. RESULT: Produced quality product market offerings fueling increased market 200% revenue increase. Engaged by the City of New York, under direction of Mayor Rudolph Giuliani, to develop and implement their Year 2000 readiness initiative, reporting directly to the Mayor. Led the Y2K Task Force comprised of representatives of all City IT departments. Developed comprehensive inventory of all IT platforms, including hardware, software, and communications components. Devised, implemented, and managed testing, remediation and reporting process. RESULT: Met goal of Y2K compliant platforms on time and within budget. In addition, the platform inventory proved to be of significant assistance in recovery in the aftermath of the 9/11 attacks. Pharmaceutical Regulatory Expertise Pharmaceutical Traceability 21CFR11 IND/NDA Clinical Trials Drug Submissions Mfg Lab Practices Research & Development PDMA Certifications Six Sigma ISO 9000 Series CRM, TQM, CMM, ABM Experience GMF CONSULTING 2/2004-12/2005 Business Process Management / Strategic Planning/ Quality/ Regulatory Compliance * Led quality oriented cost reduction projects for a variety of companies to reduce non-value added activities. Continuously evaluated/constructed/implemented client infrastructure design/enhancements for companies to increase customer satisfaction and increase the bottom line. Evaluated technical project specifications, formulated technical solutions, and made solution recommendations to the Executive branch. * Improved quality of FDA Compliance by designing and implementing a Global Audit Structure, which conducted clinical and non-clinical audits to assure compliance with Good Clinical Practices (GCP) and Good Manufacturing Practices Guidelines (GMP.) Reengineered structure and guidelines for the Clinical Trials Department. RESULT: Significantly minimized risks of possible profit-draining FDA penalties. * IMC Associates (formally REG): provided strategic in-house sourcing services. The Galaxy Group, Inc. (Parsippany, NJ) 4/2002 - 2/2004 Quality Officer * Responsible for strategic planning for compliance solution tool and directing the compliance process required by governmental agencies to ensure quality installation, operations, and performance. * Appointed to the board of director\'s continuous improvement task force to streamline the life cycle business practices. Dendrite International, Inc. (Morristown, NJ) 8/1999-4/2002 Executive Director * Responsible for designing strategic planning and directed implementation of an end-to-end software research and development organization including six functional departments to deliver Sales Force Automation software to pharmaceutical firms. Hands-on and from the ground up -- Conceived, developed, implemented, and directed staff and systems that supported six departments in a client-server environment. * Increased number of clients in excess of 200% within 2 years from 5 shares to 30 share --Developed government frameworks (Validation, PDMA and 21CFR11, Clinical Trials) towards federal guidelines to meet compliance of regulations. * Quality Assurance & Regulatory Departments - (Using PVC, Clarify Load tester; Load runner; Rational, Remedy; QLogic; Truetrak; SQATest; QADirector; Winrunner; Tools), Primary Testing Strategy Encompassed Test Plans and Documentation. o Types of tests conducted for each release: * Requirement/Enhancement Validation Testing * Regression Test * Functional Test * System Integration Test * Stress Volume Test * Acceptance Test * Established version-labeling schema for all configurations for change control. * Responsible for entire validated delivery package to customer including procedures, release notes, operational documents, specification documents in a CMM format. RESULT: Produced quality product market offerings fueling increased market 200% revenue increase. Significantly minimized risks of possible profit-draining FDA penalties. Office of the Mayor of New York City (New York, NY) 1/1998-8/1999 Executive Director * Established strategy and successfully implemented Y2K readiness plans/contingencies for all City agencies. Responsible for conceiving/designing Year 2000 Strategic Plan/Operations/Contingencies and Implementation for agencies of the City of New York. * Conducted hands-on Security / Risk / Data / Solutions Management * Spearheaded, designed, developed, implemented Year 2000 strategic plan for City Agencies\' software application and hardware used by City Agencies (including contingency plans). * In charge of entire methodologies, complete implementation rollouts, and test procedures using Rational Robot to bring their technology to Year 2000 compliance. RESULTS: Overall results: No Year 2000 exposures Met goal of Y2K compliant platforms on time and within budget. In addition, the platform inventory proved to be of significant assistance in recovery in the aftermath of the 9/11 attacks. Independent Consultant (New Jersey, New York, Connecticut) 8/1996-1/1998 Project Leader Performing hands-on and being responsible for leading project teams in designing infrastructures to meet regulatory guidelines and standards, reducing response times by 75%. Clients: Volkswagen of America, Lucent Technologies, CPC International, Amano, Lipton, Schering-Plough, Chubb Institute RESULT: Produced quality product market offerings fueling increased market 200% revenue increase. Johnson & Johnson (New Brunswick, NJ) 10/1991-8/1996 Technical Analyst * Responsible for designing and implementing strategic plans and system for streamlining J&J Hospital product distribution throughout the US and Europe. * Ensured product classification for customers, provided maintenance for conversion/migration solutions, problem resolutions, and system enhancements for new software packages and complete project rollouts including training J&J hospital product distribution methods. RESULTS: Efforts rewarded - received the prestigious Johnson & Johnson President Award and Certificate of Merit - 1995-2000 Strategic Plan Electronic Data Systems (Government) (New York City) 2/1987-10/1991 Director and Business Analyst * Accountable for developing a full documentation/training department and creating SDLC methodologies. * Reviewed, analyzed, and evaluated business systems and user needs; formulated systems to parallel overall business strategies; Wrote detailed description of user needs, program functions, and steps required to develop or modify computer programs. * Managed large documentation division of 25 employees for 11-sub system mainframe. RESULTS: Established and managed Quality Assurance strategies with heavy client interaction. Awards Johnson & Johnson President\'s Award Ideas in Action Award Associations Quality New Jersey Regulatory Affairs Professional Society Drug Information Association PhRMA - Pharmaceutical Research and Manufacturers of America ChemPharma - Chemical and Pharmaceutical Society NAFE - National Association of Female Executives Education and Advanced Training Computer Science Institute, A.A. 1985 4.0 Grade Point Average UW - (Business Administration / Child Psychology (2 yrs.) Project Management University - PMI Certification Total Quality Management ISO Series Certification Six Sigma Green/Black Certifications Sarbanes Oxley Training SEC Training Katharine Gibbs - Business Cert Professional associations QNJ - Quality New Jersey RAPS - Regulatory Affairs Professional Society DRI - Drug Information Association PhRMA - Pharmaceutical Research and Manufacturers of America ChemPharma - Chemical/Pharmaceuticals Association NAFE - National Association For Female Executives TECHNICAL EXPERTISE PLATFORMS AND SERVERS Oracle, Hewlett Packard Client Servers such as HP3000, HP5000, & HP9000; NT Servers; Compaq; Sun Workstations; IBM 3090-300J; 3090-600J; ES/9000 models 720 & 920; IBM 3081; IBM A/S 400 Model E60, 320, 620, 640, 730, 740; RS/6000 AIX Model H50, HP Imaging System, IBM MP2003 PERIPHERALS Disk Drives: IBM 3380 Models 1,2,3, IBM 3390 Models 1&2; Disk Drive Controllers: IBM 3880 Models 1&2, IBM 3990 with cache memory; Tape Drives: IBM 3420, 3480, 3490 and 3590; StorageTech 9710 Tape Library Storage Unit; Printers: IBM 4248 and IBM 6252 impact printers, IBM 3827 and 3825 cut sheet laser printer, Xerox 4050, 4090, 4635, DP96 cut sheet laser printers; Tele-Communication Controllers: IBM 3725, IBM 3745 Model 410. OPERATING SYSTEMS 98, NT, 2000, XP, UNIX; JES-2; VM/E-Mail; DecVax/VMS; OS/2; IBM VSE/ESA; OS400. DATABASES DB2/UBD; Sybase; TSO; CICS; Oracle, Sybase, SAP, ERP NETWORK AND PROTOCOLS Local Area Network; Wide Area Network; PBX\'s; ISDN; Novell; Token Ring; Ethernet; SNA; TCP/IP; EDI, XML