CSV - QMS - TQA - PM
Resume:
Stan SCHULMAN
Have Solutions – Will Travel
***********@*******.***
EMPLOYMENT HISTORY
• Program / Project Specialist, Freelance, 4/12-
• Managing Consultant, IBM, 9/10-3/12
• Lead Consultant, Falcon, 2/09-4/10
• Project Manager, Covex, 5/07-1/09
• Sr. Project Manager, US Data Management, 7/05-2/07
• Global Project Lead, Jacobs Engineering, 1/03-2/05
• Director, Indus International, 9/98-12/02
• Principal Consultant, CSC, 6/96-8/98
• Lead Associate, Weinberg & Associates, 8/90-6/96
• Sr. Project Manager, Sanchez Computer Associates, 6/86-8/90
• Technical Account Manager, Boeing Computer Services, 3/80-5/86
• Assistant Vice-President, Washington Federal, 4/71-3/80
• Specialist Five, U.S. Army, 3/69-3/71
• Accountant, Macys, 6/68-3/69
EXPERIENCE
• Managed program, project delivery
• Implemented, configured, maintained commercial off-the-shelf systems
• Prepared, executed, managed computer system commissioning, qualification, validation
• Provided technical quality assurance and audit for GxP systems, financial compliance controls
• Ensured compliance of regulated systems and remediated deviation findings
• Conducted business process, system process analysis, re-engineering
• Led cloud, application-as-a-service, service provider system-as-a-service, service bureau operations
DELIVERABLES
Requirement specifications (user, functional), system selection, application configuration, risk assessments, gap analysis, plans (master, system), qualifications (design, installation, operations), acceptance testing (user, factory, site), audits (technical quality assurance, vendor), reports (summary, system), traceability matrixes, releases (approval, go/no-go, procedures (standard operating, policy, desk reference), change control, training (courses, mock audits), system documentation, business development (information responses, proposal requests, presentations)
SYSTEMS
Document management (IBM, EMC, CSC, NextDocs, JPI), enterprise resource planning (SAP P2P, OTC, MM, WM, PP, QM, SD; JDE), asset maintenance management (Oracle, Ventyx), statistical process control (InfinityQS), corrective preventive action (Trackwise, eQCM), customer relationship management (Dendrite), electronic signature (VeriSign, Adobe Acrobat), interactive voice response (Oracle, UBC), patient outcome reporting (ePro), data capture), preclinical (Labcat), clinical trials (Medidata), laboratory information management (LabWare), laboratory robotics (Blue Sky), blood processing, blood processing, data warehouse (Kalido), manufacturing automation (Johnson, Yokogawa, Rockwell, Allen-Bradley), building management (Rockwell), cloud provisioning (Tivoli)
Productivity tools (MS Word, Excel, PowerPoint, Outlook; Visio, Project; Lotus Notes)
CLIENTS
IBM, Eli Lilly, Covance, Express Scripts, Avid Radiopharma, BioMarin, Daiichi-Sankyo, Macrogenics, Shire, URL Pharma, Boston Scientific, CSL Behring, Infinity QA, Sanofi-Aventis, Draxis, Analogics, Calvert Labs, Elan, PAI / Beach, Salix, American Red Cross, Boehringer-Ingelheim, Alcoa, Great Northern Paper, NYC Board of Ed, Sunoco, Sikorsky, US Steel, Vermont Yankee Nuclear, Allergan, GSK MerkKgaA, Roche, Schering AG, BloodTrac, Charles River, J&J, Merck, Roche Diagnostics, Alcon, Astra Zeneca, Baxter-Hyland, Canadian Red Cross Society, Johnson-Yokogowa, McNeil Labs, Monsanto, Novartis, Novo Nordisk, Pfizer, Bank of Bermuda, Farm Credit Bank, Federal Home Loan Bank
EDUCATION
B.A., Economics, City University of New York City College
WORK DETAIL
IBM
• Prepared, executed, managed quality compliance program for outsourced regulated operations
• Prepared, executed, managed Cloud quality management and validation programs and infrastructure qualification
• Prepared, executed, managed laboratory information management system legacy system data conversion testing
• Managed technical project delivery of Medicare, Medicaid program prescription program
Falcon
• Prepared, executed, managed electronic signature system validation
• Prepared, executed, managed clinical trial management, data capture, data warehouse, interactive voice response, patient outcome reporting system technical quality assurance audits
• Provided document management system validation technical quality assurance oversight
• Prepared, executed, managed request for proposal, selection of document management, pharmacovigilance safety surveillance systems
Covex
• Prepared, executed, managed statistical process control, enterprise resource planning (purchase-to-payment & order-to-cash processes, customer relationship management) processes, automated labeling system, interactive voice response system validations
• Prepared quantitative risk-based quality assurance process for management of clinical trials
• Prepared, executed, managed interactive voice response system technical quality assurance audit
• Provided technical quality assurance oversight of document management electronic change control system validation
US Data Management
• Prepared, executed, managed corrective preventive action, preclinical, enterprise resource planning (material management, warehouse management, production processing, quality management, sales & distribution modules) system validations
• Prepared, executed, managed verification of key financial compliance audit controls
Jacobs Engineering
• Managed system commissioning, qualification, validation of ‘green field’ site
• Prepared, executed, managed preparation of design qualification turnover packages
• Prepared, executed, managed building management, qualified utility management, distributed control system technical quality assurance audits
• Prepared organization, set-up of asset maintenance management system input
• Prepared, executed, managed blood processing facility-commissioning program
Indus International
• Managed asset maintenance management system implementation project operations
• Managed corporate troubleshooting of ‘at-risk’ project operations
• Prepared, executed, managed ISO quality management system with continual improvement metrics
• Served as industry solutions subject-matter-expert for FDA regulated compliance
CSC
• Prepared, executed, monitored national, international validation programs
• Managed remediation of FDA consent decree
• Prepared, executed, managed enterprise resource planning (materials management, quality management modules), document management, laboratory information management system validations
• Prepared, executed, managed drug development thru product delivery document management system implementation
• Prepared, executed, managed inter-company supply-chain financial control processes
Weinberg & Associates
• Prepared, executed, managed AIDS reporting call center, blood processing, blood fractionation, building management, preclinical, patient outcome reporting, laboratory information management, manufacturing automation system validations
• Prepared, executed, managed validation programs, manufacturing automation, manufacturing quality controls, document management, system technical quality assurance audits
• Managed remediation of laboratory information management robotics system FDA 483 citation and served as expert witness
Sanchez Computer Associates
Led implementation of banking software systems for domestic, governmental, international projects
Boeing Computer Services
Led support services of N.E. region banking financial application service provider system-as-a-service operations
Washington Federal
Managed region branch banking operations and bank-wide service bureau financial system operations
Macys
Supported corporate tax office operations
TRAINING
• Computer System Validation: Daiichi-Sankyo, Eli Lilly, ISPE, McNeill Labs, Merck, Roche
• Quality Management Systems: Det Norske Veritas RBS ISO 9000 Audit Certificate, CMMI
• Project Management: Boeing SSDM, CSC Catalyst, CSC Pioneer, FDA Waterfall, ESI iDeliver, IBM WWPMM
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