Pharmaceutical and Medical Device Consultant for Portfolio Strategy, IT, Systems Design and Operational Excellence

Expertise

• Over 16 years in the pharmaceutical, medical device, biotechnology and healthcare industries.
• Subject matter expert in health care product portfolio management, project management, operational excellence, quality system improvements, system development life cycle (SDLC), computer system validation (CSV) and regulatory compliance in global operations.
• Assessments of business operations, quality assurance programs, regulatory, compliance, information technology and manufacturing supply chain.
• Portfolio, program and project management, Project Management Operations (PMO).
• FDA and international regulatory compliance.
• IT and IS; development and infrastructure management.
• Enterprise resource planning, (ERP) and operational assessment of manufacturing systems and supply chain.
• Lean, six sigma, Kaizen, Best Practice Management (BPM), change management.
• Use of systems development life cycle, Security Development Lifecycle (SDLC) methodologies.
• Computer System Validation (CSV) and Part 11 compliance to improve organizational efficiently and reduce errors.
• Pharmaceutical and medical devices compliance audits, regulatory assessments and reviews.
• Documentation management Standard Operating Procedures (SOPs) and use of Electronic Common Technical Document (eCTD) technology.
• Compliance audits, assessments, and reviews.
• Quality assurance and regulatory affairs.

Experience

Undisclosed Company, President, 1994 - Present

• Consulting company serving the pharmaceutical, medical device, biotech, and healthcare industries.
• Senior executive and principal consultant in operational excellence, process improvement, portfolio/program/project management, quality and regulatory compliance, and information technology products and service firm.
• Advisor for operational excellence, process improvement, quality system improvements, product development programs, lean and six sigma DMAIC process programs, business process management (BPM), and business process re-engineering (BPR).
• Expert in portfolio, program, and project management, PMO establishment and governance, and high performance team building. Managed teams of over 120 people and budgets of $100 million.
• Automatic Identification and Data Capture (AIDC), Radio-frequency identification (RFID) and Electronic Data Capture (EDC) systems expert.
• Operations management, strategic planning, (CRM), portfolio, program and project management, sales and marketing, contracting and (ROI) analysis.
• QA and QC, regulatory affairs, regulatory compliance, management control, verification and validation, (CSV and Part 11).
• Trend Analysis, CAPAs and CAPA gap assessment reviews, nonconformance resolution, DHF reviews, performing Root Cause Analysis (RCA) and Failure Investigations, FMEA and FMECA.
• Internal and external audits including FDA audits, FDA regulatory submissions (NDAs, INDs, 510Ks and PMAs).
• IT improvements, product development and management, ERP system (SAP, JDE, MS Dynamics) implementations and system architecture.
• Validation master plans (VMPs), validation strategy plans (VSPs), quality assurance including software quality assurance (SQA), quality audits, validation reviews and remediation, electronic data capture (EDC), process control, workflow analysis.
• LO1 Tracker System designer, developer and implementer utilizing AIDC and RFID technologies to facilitate data capture, data integrity and operational efficiencies.
• U.S. and international regulations, guidelines, standards, and "industry best practices" including, but not limited to, GxPs, ICHs, Quality System Regulation (QSR), ISO 9000, 13485 & 14971, 21 CFR Part 11, Annex 11, IEC 62304, MDD, CMDR, EMEA, GAMP 5, GDMP, IEEE, Six Sigma DMAIC, PMI/ANSI PMBOK, HIPAA and SOX regulations.
• Quality systems training and programs.
• Management techniques and SCRUM. Compliant with FDA, ICH, ISO, EC, and EMEA standards.

Undisclosed Company, Chief Operating Officer, 1995 - Present

• Management consulting and professional training Service Disabled Veteran Owned Small Business (SDVOSB) specializing in portfolio, program and project management.
• Project Management Institute (PMI) Charter Registered Education Provider (R.E.P.).
• Operations, profit and loss, administration, marketing, business duties.
• Project Management Institute (PMI) Charter Registered Education Provider (R.E.P.).
• Subject matter expert consulting: Portfolio, program and project management, IT, leadership, teambuilding, risk management, earned value, critical chain method, PMO establishment and governance.
• Products developed: Leadership Assessment Tool (LAT), the Project Auditing Tool (PAT), Instructor Led Training (ILT) and Web-Based Training (WBT) courses.
• Perform instructional design and course development services.
• Federal contracting, contract administration, business case development (OPM 300), and the Federal Enterprise Architecture. Proposal preparation and reviews. Solid working knowledge of the FARs. Administer FAA, GSA MOBIS, and GWAC IDIQ contracts.
• Key U. S. government agency customers include DFAS, DOD, DOT, FAA, GSA, and NOAA working with executives, program and project managers, engineers, research scientists, and information technology professionals.
• Developed portfolio, program and project management career development matrix with core competencies and proficiencies for career development and progression for the Federal Aviation Administration (FAA), adopted by the U.S. CIO Council for use in executive branch agencies.
• Developed the GSA government executive portfolio, program and project education program under the GSA Star Program, a highly successful program lauded for its effectiveness given the highest rating for excellence.

Sabre Systems and Services, Senior Vice President and Business Unit Head, 1991 - 1994

• Led a $25 million information technology products and services division of an operating company, hired to restore balance, revenue growth and profitability.
• Managed a portfolio of up to 117 projects with team of 75 personnel.
• Accountable for full profit and loss, engagement management, customer relationship management, product portfolio, new product development information technology data center management.
• Directed IT development organization, infrastructure, and data center for accounting, payroll, finance, treasurer and auditor systems.

Professional Highlights

• Yielded $250 million in client estimated operational savings.
• Process Improvements with $60 million in client documented annual savings.
• Rescued a Top 10 project now exceeding $500 million annually in new revenue.
• Launched LO1 Tracker System on time and on budget and reducing operating cost over $10 million annually.
• Plant Renovation generates revenue over $300 million annually.
• Designer and developer for a custom Just-in-Time (JIT) product configuration and order processing system a medical device manufacturing and distribution company with client reporting approximate new annual revenue of $12 million.

Academic and Professional Affiliations

• Project Management Institute (PMI).
• PMI Aerospace and Defense Specific Interest Group (A&D SIG).
• PMI Information System Specific Interest Group (ISSIG).
• Chief Information Officer Network (CIO).
• Dayton Area Defense Contractors Association (Dayton Defense).
• American Society for Quality (ASQ).
• American Society for Testing and Materials (ASTM International).
• International Society for Pharmaceutical Engineering (ISPE).

Publications and Patents

• Author and Co-Author of chapters in textbooks, research papers, workshops, training courses and presentations.
• Invited Speaker: Featured presentation at the PMI Project Management Research Conference.

Education

• PH.D. Project Management, University of Strathclyde, Glasgow, United Kingdom
• MBA Industrial/Production Management and Economics, Wright State University, OH
• B.S. Business/Computer Science, Wright State University, OH