My Resume

Resume for Richard W. Burkart

• Cell Phone in Panama: 507 6787-0609
• Email: richard@panamamundo.com
• Address: 24 Avenido Roberto Eisenmann, Coronado Panama
• Languages: English, French, increasingly better Spanish

Work Summary:

• Senior business analyst and business strategist (20+ years)
• Project Management (11+ years)
• Real Estate Development (15+ years)
• Pharmaceutical validation (8+ years)
• Full life cycle software systems development (11+ years)

Recent Projects and Assignments

Panamian Construction Projects : (May 2005 to July 2008) Constructed four large "high end"(more than 4000 SF) residences in Coronado plus major renovations on four other projects. Currently working on 5 projects with about 50 workers.

Grupo Moreinis: Conducted business analyses and real estate appraisals for 12 large development properties comprising approximately 800 hectares.

Cardinal Health. San Diego CA: March 2006 to September 2006. SAP project management.

Amgen Corp. Thousand Oaks CA: October 2005 to February 2006 as Validation Lead for a $200 million IBM project to validate a global installation of SAP/R3.

Book on Panama (2006-2007): Wrote and published a 300 page book on the rationale of living and retiring in a low cost developing country with a focus on Panama.

Artemis International Solutions (USA and France): (December 2004 to April 2005) Developed a pharmaceutical solution for portfolio management using the Artemis A7 software model. The solution used "stage-gates", "scenario analyses", and "scorecard balancing" to optimize R&D productivity and ROI within a new product development pipeline. 

Johnson & Johnson, (Puerto Rico, NJ, and Miami Lakes): (July 2004 to October 2004). Acted as project leads to analyze protocols for 1500 "manufacturing systems" including software systems. Developed a relational database to produce the required FDA reports for remediation purposes and extended the database for use at the enterprise level.

Wyeth Pharmaceuticals (Pearl River NY): (May 2003 until June 2004). Engaged as Project Manager and hired a team of 15 validation experts for the remediation and validation of approximately 400 software systems to FDA standards. During this period Pearl River was under an FDA "Consent Decree".  Responsibilities included management of an annual budget of $5.0 MM for operational and capital expenses.

Schering-Plough Corp (Madison NJ): (March 2003 until May 2003). This assignment included drafting ten life cycle software Standard Operating Procedures for use as site standards.

Purdue Pharma (Totowa NJ): (August 2002 to February 2003). Responsible for conducting full software system assessments including gap analyses and remediation. Remediated 10 large computerized manufacturing systems to 21 CFR Part 11 standards. Responsibilities included full life cycle validation of new and upgraded software systems (Validation Plans, User Requirements Specifications, system specific SOPs on security, audit trail and backup/recover, regression test scripts, traceability matrices and Validation Summaries).

Schering-Plough Corp (Kenilworth NJ): (October 2001 until July 2002). Responsible for conducting in-depth assessments and gap analyses of GXP software systems used in the manufacturing division (approximately 400 GXP systems) to FDA 21 CFR Part 11 standards. Identified and reviewed remediation scenarios with system owners that ranged from procedural to technical solutions to address system replacement, re-validation requirements, enhanced audit trails, security issues, and decommissioning.

Schering Plough Corp (Kenilworth, NJ): (May until Sept 2001) as Project Manager for the full life cycle validation of two major software applications. One system was based on Documentum 4i for use by Worldwide Regulatory Affairs. Responsibilities included the creation and review of all full life cycle project documentation for compliance with 21 CFR Part 11 regulations. A particularly active role was taken to draft approximately 300 test scripts for the integration testing phase of this system. Worked closely with clients to understand the basic business processes. The second project was a PowerBuilder application to track and manage Worldwide Regulatory Affairs communications and commitments to International Health Authorities.

Pfizer, Inc. (Groton CT): (February 2001-April 2001). Acting in a QA role, primary responsibility was to manage and review all project documentation for the development of an enterprise PeopleSoft software application to ensure compliance with FDA 21 CFR Part 11 regulations and Pfizer corporate guidance. The application was a complex Inventory system for the R&D Clinical Division including several global sites. Conducted various compliance audits of project documentation. Reviewed and approved all project documentation from concept stage to testing and deployment. Interacted frequently with end users.

Glaxo-Wellcome Pharmaceuticals (Singapore and Slough, UK): (June/99 until May/00). Participated as Singapore Lead on validation task force for a large SAP/MRP software project (1200 team members with a $200 MM budget for six sites). Project implemented the FI, SD, MM, and PP modules. Primary responsibilities addressed software validation and compliance issues with particular attention to data migration and related 21 CFR Part 11 compliance in Singapore. Drafted Standard Operating Procedures (SOPs) at the site and corporate level. Planned and participated in the SAP Post Implementation Review process. Conducted documentation assessments and audits on all aspects of the implementation. Audited system and integration testing in Singapore. Authored validation plans, test plans, and test scripts, and summary reports as required. Conducted post implementation QA audits. Acted as Team Lead for the last six-months to develop a global strategy to implement Documentum 4i as an enterprise solution for documentation. Strategy included interfacing with 6 existing enterprise software applications.

Warner Lambert Pharmaceuticals (Paris, France): (Nov. 1998 to March 1999). Primary responsibility was to ensure FDA compliance for a GxP SAP Sales and Distribution (SD) software application in Paris. Drafted related Standard Operating Procedures (SOPs). Acted as primary auditor and QA for project documentation including functional requirement documents, system design specifications, test scripts, and final summary documentation. Verified that documentation met 21 CFR Part 11 requirements. Conducted the QA audit on 3000 pages of bespoke SAP/ABAP code.

Citibank Corp (Singapore): (Oct/Nov 1998) for a SAP/EDI project. Primary responsibility was to work closely with Citibank SAP clients throughout South East Asia to optimize SAP/FI EDI connectivity for Accounts Payable and Accounts Receivable.

Siemens Telecom Networks (Boca Raton, USA): (April/98 to Sept/98) as a SAP Functional and Senior Business Analyst. Developed functional requirements and technical specifications specifically for BAPIs to permit data transfer between a new VB Customer Service application and SAP R/3. Tasks included data modeling, web design and relational database development. Also conducted a software audit and evaluation of all major OLAP applications for a data warehouse initiative related to this project.

National Council for Compensation Insurance (Corporate Headquarters Boca Raton, USA): (1997-1998) as a Senior Business Analyst. Primary responsibility was to review relevant business processes to design/build a web-based, software application for NCCI clients based on a full life cycle approach. Developed an application called "Claims BenchMarker". The application generates sophisticated comparison benchmarks for product mix decisions in this insurance industry sector.

Technisource, Inc. (Corporate Headquarters Fort Lauderdale, USA): (1997 10 months). As Lotus Notes Practice Manager had responsibility to negotiate strategic partnerships with major Lotus Notes software companies that had developed applications in Sales Force Automation, Customer Service, and Help Desk areas. Developed new business by marketing these products together with related consulting services to Fortune 500 Technisource clients.

Interim Services, Inc. (Corporate Headquarters Fort Lauderdale, FL): (6 months 1996-97) as Senior Business Analyst. Responsible to analyze business requirements and scenarios for a major HR software application ($25mm) for this NYSE company.

Bank of Boston (Corporate Headquarters Boston, MA): (5 months 1996) as Senior Business Analyst. Conducted analysis of 75 bank investment products and support systems with a focus on security issues, derivative products, and computerized software systems to assure compliance with Federal Reserve Board regulations for a new corporation called BancBoston Securities Inc. Primary task was to identify and understand all "fire-wall issues" to ensure client privacy throughout the enterprise. Drafted new software system specifications. Authored the final report for team.

ALI Technologies, Inc. (Boston, MA): (7 months 1995-96). Lotus Notes software developer. Developed a complex value-based sales opportunity, software application (SFA) for a large NYSE Company in Rhode Island. Developed a Lotus Notes sales relationship tracking application for a major investment research and securities company. Developed the design and architecture for a Lotus Notes workflow application to manage telecommunication switches for NYNEX.

Agriculture Canada (Ottawa, Canada): (1995) as a Project Manager, Business Analyst and software developer. Designed/developed an HR relational database application to manage personnel issues including staff relations, grievances, classification, and promotions for a major government department.

Department of External Affairs (Ottawa, Canada): (1994-96) as Software Developer and Project Manager. Developed a complex relational database application for a telecommunications inventory management and billing system. This application was implemented by three government departments having 20,000 communication ports. The program tracks and manages all telecommunication devices including telephony features, rental charges, usage fees, installation requirements, cabling plans, and voice/data outlet locations by number, person and location. It automatically reconciles monthly invoices to ensure proper charges.

Agriculture Canada (Ottawa, Canada): (1994-95) as a Software Developer and Project Manager. A rather unusual but very challenging project. Developed a comprehensive relational database based on 45 system tables to track and manage the breeding of 50,000 chickens in the largest global facility of its type.

Department of External Affairs (Ottawa, Canada): (1994) as a Software Developer and Project Manager. Developed a real estate relational database software application to manage the physical attributes of 2500 Canadian embassy properties worth approximately $3 billion CDA and located in 150 countries.

Canadian International Development Agency (Canada and USA): (6 months in 1993) as a Senior Business Analyst. Drafted a feasibility study for a $100 million Government financing facility for Africa. This "development bank" provided loan guarantees to small-scale entrepreneurs. Extensive interviews were conducted with senior banking, trade, and venture capital representatives throughout Canada and the World Bank Group in Washington.

United Nations Development Program (New York, USA): (6 months in 1992-93) as Senior Business Analyst. Conducted business analyses and QA evaluations concerning the effectiveness of software information feedback systems within the UNDP to manage their 4000 international development projects. Interviewed senior directors at World Bank Group and UN agencies throughout Europe, the Caribbean, and Latin America. Authored the final report for circulation to all UN members.

Energy Mines and Resources Canada (Ottawa, Canada): (5 months in 1992) as Senior Business Analyst. Drafted a scenario analysis for the long-term supply and demand of Canadian minerals, metals, and energy industries. Conducted extensive research and interviewed CEOs across Canada.

Canadian International Development Agency (Bangladesh): (6 months in 1992-93) as a Senior Business Analyst. As a member of a small team conducted a formal evaluation of the effectiveness of Canada’s largest food aid project (Bangladesh). Task included travel to Bangladesh for one month.

Energy Mines and Resources Canada (Ottawa, Canada): (5 months in1991-92) as a Senior Business Analyst. Authored a strategy policy paper for energy, metals, minerals and research branch with a 15 year horizon. The final document identified major policy initiatives with recommendations to the Minister.

Canadian International Development Agency (Ottawa, Canada): (3 months in 1992) as Senior Business Analyst. Drafted an investment strategy paper for CIDA Asia Branch to enhance private sector partnerships with Canadian companies.

Nordion, Inc. (Ottawa, Canada): (12 months during 1989-91) as Business Analyst. Authored two major technical manuals (200 pages each) to document all manufacturing processes and sub-processes for medical radioisotopes for FDA purposes. Nordion is the largest global producer of medical radioisotopes.

Real Estate Developer (Canada, USA, Thailand and Panama): During the period 1976 to present developed a number of major real estate projects for my own account including a 70 unit luxury condominium project in Almont Ontario.

Economist (Ottawa, Canada): Full time position (1972-79 as Economist and Policy Analyst). With External Affairs, duties were to draft comprehensive economic, strategy and business policy position papers for Cabinet approval and present these positions at international conferences.

Education

University of Windsor: Honors Economics and Political Science.

McGill University: All Masters course work completed in Economics (no thesis).