Consultant providing Information Security Management System design * Controls Assessments * Risk AssessmentsComputer System Validataion * GXP Computer Validation Services. Policies, SOPs, Master Plans, IQ, OQ, PQ scripting and executionhttp://www.linkedin/company/cyberfit

Management of and Consulting on Corporate Information Security Policies.Created, refreshed, assessed second line of defense for centralized global information security policies and controls standards. Refreshed within 12 months Information Security Policy and Standards. Owned integrated Information Security controls into the IT Policies and Standards. Created timely expert advice to IT and global business units on Information Security policy and standards.

Manage the global implementation of SAP QM in Fabric Care and Home CareLed the global household care business unit to implement an SAP/QM/BM in 53 manufacturing plants. Directed a team of regional leaders on how to design and deploy SAP batch management and SAP quality management module in manufacturing plants. Served as program manager leading implementation of SAP QM and BM in North America.

Senior Project Manager - Consultant - assisting clients with project management, business analysis and quality assurance needs.Guided global design, development and implementation of consumer web site marketing initiatives. Led design and execution of product claims approval software system.

Project ManagementRegulatory Business SystemsRegulatory Operations Business AnalystRegulatory Publishing and Document Management Specialist.Knowledge Management SpecialistStructured Product Labeling (SPL) Process ExpertTest script design, analysis, review and approval

Responsible for defining what compliance to 21 CFR Part 11 meant, leading the organization compliance efforts, and overseeing compliance.• Led a cross functional team (IT, Clinical Data Management, Clinical Operations, Regulatory) to define the business impacts of the FDA guidance for “Computerized Systems Used in Clinical Investigations” ensuring processes and computer systems were compliant. • Defined the quality system for Part 11 compliance, integrated it into the R&D quality process and changed the committee’s focus from compliance oversight to new FDA guidance and regulation.

Accountable to Regulatory Affairs for the Pharma R&D Electronic Documentation system. • Drove upgrade and simplification projects and maintained compliance, and reliability of the Documentum based system used to build and archive product dossiers. • Reduced support costs by approximately $1.5 Million by strategically choosing the upgrades necessary which reduced overhead costs • Coached IT and business resources as they became familiar with the compliance SOPs that assured regulatory needs were met resulting in a more capable and efficient team and making resources available for other projects.• Worked with business functions (Clinical Data Management, Drug Safety, Bioanalytical, Regulatory, Clinical Operations, CMC QA and IT) to design and implement processes to classify electronic documentation.• Maintained the knowledge base data model, data dictionaries and procedures related to updating content resulting in an expanded use of the system and a reduction in the use of paper records.• Redesigned Regulatory computer validation plan that reduced the validation effort 75%.• Test Script design, analysis, review, and approval

Represented Regulatory Operations on the committee.• Led the timely completion of the Regulatory Operations ER/ES “Functional Compliance Plan” bringing computerized systems into compliance. • Provided input into improving SOPs ensuring FDA software quality requirements were met.

Reporting to Regulatory Affairs, led a project team with IT to analyze new software revisions and update training and work processes. These efforts enabled the business to meet changing regulatory needs, take advantage of technology improvements and improve efficiency of operations. • Redesigned related work processes and implemented changes to systems, in response to management’s decision to outsource major submissions to lower operating costs (eliminate 4 FTEs) and improve capability to handle the peaks and valleys of submission production.• Provided first line support for 10 Publishers and Dossier Managers for the “always on time production” of Marketing Applications in the USA, Canada and EU.• Test Script design, analysis, review, and approval

• Webmaster - Pioneered the use of the intranet for the Cincinnati site. Lead the North Intranet Team in developing Intranet Standards. Lead a team from Human Resources and Communications to design and rollout the Cincinnati Site Intranet. • Web Developer - Pioneered the use of web development tools for the Cincinnati Intranet. Primarily: FrontPage 97, 98, 2000. Visual Interdev, VBScript, JavaScript. Developed a variety of static and dynamic pages utilizing forms, Internet Data Connector, ADO, Access, Oracle and SQL-Server. Among the applications developed for the Intranet were: Catering Order web site; Office Supply Ordering web site (interfacing to EDI to the Office supplier); Critical regulatory system for displaying Standard Operating Procedures (SOPs).• Client Server Developer - Selected to customize the first Visual Basic application for the Cincinnati Site. The software automatically distilled Microsoft word documents into PDF document and cataloged the file related information into a SQL Server Database.

Computer Systems Regulatory Specialist. - Responsible for auditing, counseling and advising on the development, deployment and maintenance of regulatory compliant systems (laboratory automation system, Electronic Batch Record system, Process Control Systems and SAP R/3). (Compliant to 21 CFR Part 11, 211, and 212).Utilizing my expertise in developing regulatory compliant systems, I provided guidance to sites in North America and to the Global Headquarters in Frankfurt, Germany to audit, train, counsel the IT and Quality Assurance organizations.Provided the Cincinnati Site with the guidance and coordination necessary to be recognized as a "World Class" level of compliance for regulated computer systems.SAP/QOIS Interface Project Leader - Successfully delivered under a fixed deadline, the design, construction and implementation phases. • Wrote all life cycle documentation reports (Definition, Analysis, Design, Construction and Implementation). • Successfully completed the Validation Master Plan. Standardized Oracle installations, SQL*NET configurations, and database creation procedures.

System Implementation Coordinator - for the Laboratory Data Acquisition computer system. • Accountable for the successful implementation of Global LAS for the Cincinnati site.• Developed Computer System and Telecommunications Specification for the implementation and support of computer systems for the manufacturing and Research laboratories. Coordinated and developed a quality system process for the telecommunications design and implementation. • Coordinated the capital, $1 million, for all computer and telecommunications purchasesComputer Validation Leader for the Global Laboratory Data Acquisition Project Team. Provided leadership for the definition and implementation of Validation Master Plans and the corresponding deliverables for Life Cycle Development deliverables and Standard Operating Procedures Global Project Leader for the applications development department providing the leadership for global laboratory automation. Responsibilities include the development and implementation of project plans. • Assigned as the project leader to spearhead an effort to migration business critical laboratory applications from Hewlett Packard computers to Digital Equipment VAX computers;• Responsible for selecting and implementing the training of analyst using 4GL application development environment and Oracle Application development environment;• Responsible for the implementation of the company's life cycle development methodology for assigned projects;• Utilized Computer Aided Software Engineering (CASE) tools to reduce the amount of effort necessary to develop cross functional and geographically disperse sites;

Senior Software Analyst for the systems/operations department providing support service for laboratory automation. Responsibilities include the support for computer and telecommunications hardware, system software, application software and the overall computing direction. • Participated as a key member of the client's coordinating committee responsible for the evaluation and selection of future hardware and software for laboratory automation, including the purchase of systems for evaluation; and• Performed the system management function resulting in over 99% up-time of four networked Hewlett Packard computer systems controlling over 130 automated instruments, on a 24 hour a day seven days a week schedule for a client base of 105 laboratory technicians and scientists in both basic research and in production quality control;