MARC BROWNSTEIN, Ph.D. Langhorne, Pa. 19047 Marc.brownstein@gmail.

com (215) 460-6015

INFORMATION SOLUTIONS EXECUTIVE Senior management position in information solutions requiring skills and experience in planning, organizing and directing business optimization, cost reduction, and quality directives providing expected solutions and services. SUMMARY Senior-level Information Systems Executive with proven professional, technical, financial management and problem-solving skills. A creative manager with a strong orientation to customer service, organizational efficiency and profitability. Excellent skills in attracting, motivating and developing employees while enforcing high performance standards. Scope of experience includes supervising crossfunctional global teams, managerial and technical employees. KNOWLEDGE & STRENGTHS audit and control procedures business analysis data center management decision support systems document management IT Governance IT Strategy and Planning ITIL methodology metrics & dashboards process improvement project management quality management regulatory- FDA, QSR, ISO risk management Six Sigma systems development training validation vendor management EXPERIENCE Sanofi Pharmaceuticals, Bridgewater, NJ 2007-Present Senior Management, IS Governance/Process & Compliance Responsible for IS project development; audit & inspection; process improvement, governance policies, procedures and controls. Supported a highly diverse IS organization of 70+ employees. * Implemented quality and methodology processes and practices for computerized systems development (100% project manager utilization, regulatory and validation compliant). * Coordinated long range plan process improvement producing operation efficiencies within IS processes: Develop and Deliver Services, HR, Finance, Security, Documentation, Purchasing, Communication, etc. * Directed Global IS methodology development/training programs and communication (600+ employees trained/implemented < than 4 months). * Launched project/application inspections & audits providing preventive and successful regulatory compliance acceptance Sanofi-Aventis Pharmaceuticals, Bridgewater, NJ 2005-2007 Senior Management, Information Management/Quality & Methodology Responsible for leading, directing and supporting IS computerized systems development.

Marc Brownstein

* Launched computerized solutions meeting validation expectations for compliance with Good Clinical, Manufacturing and Laboratory regulations, and internal standards (Discovery, Drug Safety, Clinical Development, HR, and Development). * Established methodology and training direction/organization for project development teams (SDLC, MS Project, Business Analysis, process improvement, validation, quality & compliance). * Implemented governance processes/standards for project/application continuous improvement (KPIs, PM metrics- Milestone Trend Analysis, Six Sigma). * Launched audit/inspection practices and processes (SOX, GXP, Data Privacy, Security, change control) providing required compliance evidence. Aventis Pharmaceuticals, Bridgewater, NJ Senior Management, Information Solutions/Quality Operations 2000-2004

* Lead/Manage North America R&D IS Quality Operations team (budget, resources, direction). * Implemented IS Quality standards (methodology, SOPs, project management, validation, training, vendor audits) * Organized IS project team/application quality support/guidance/mentorship * Establish/Promote/Communicate cross divisional (infrastructure, security, legal, finance, corporate, quality assurance) quality processes, standards and guidelines. * Implemented compliance program (assessments, compliance strategies, procedural and technical remediation). Rhone-Poulenc Rorer, Collegeville, PA Global I.S. Manager, Methods/Compliance/Security * Responsible for global I.S. quality infrastructure organization. Established direction for standards, tools, methodology, and communications providing computerized business applications supporting regulatory compliance, security and return on investment expectations. Rorer Group Inc., Horsham, PA Manager Strategic Integration, Information Systems * Increased research information integration 40% with 90% manual workload reduction. * Implemented five-site information network system to enhance company productivity with reduced costs. Optimized New Drug Applications FDA filing resulting in $4 million dollars/month estimated market earnings per new drug compound. * Successfully proposed to executive management 5-year strategic company systems information platform to resolve pain areas, and establish and sustain cost effective competitive market advantage. Phase 1 $6.6 million dollar executive board approval. * Provided leadership and tools to generate information within FDA compliance regulations to initiate early decision. Estimated $18 million annual savings via early market share. EDUCATION Ph.D., Biomedical Engineering, Drexel University M.S., Biomedical Engineering, Drexel University B.S., Physics, University of Pittsburgh
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