Paul J. Moran


Management and technical professional with solid quality assurance, technical service, and compliance knowledge. Extensive experience with large multinational corporations, contract manufacturers, and small start-up companies in regulated environments within medical device, drug, drug-device combination product, and consumer product manufacturing industries. Background in implantable devices, surgical instruments, wound care products, plastics, adhesives, and Rx and OTC drug products.


  • Design Control/Design Changes Quality System Development/Procedures
  • Design Reviews/Design History Files 21CFR Parts 820/201/211
  • Material Specifications/Supplier Specifications ISO 9000/ISO 13485
  • Quality Engineering/Assurance/Control FDA Inspections/Remediation
  • Process Controls/Manufacturing Procedures Quality Audits/Gap Analysis
  • Process Validations/Process Capability Product/Process Audits/DHF Audits
  • Molding/Thermosets/Thermoplastics Product Recalls/Medical Device Reporting
  • Change Controls/Engineering Change Notices Establishment Registrations/Device Listings
  • Complaint Handling/CAPA FDA/ISO Training/Audit Training


  • Provided consulting support and completed compliance activities for various medical device and drug manufacturers, including:
    • Wrote and managed approvals of various procedures relative to quality systems in drug and medical device locations.
    • Audited Class I-III devices, including drug-device combination, Rx, and OTC pharmaceutical manufacturing plants from multi-nationals to start-ups.
    • Developed full quality system for medical device start-up company.
    • Developed and completed design history files (DHFs).
    • Audited design control systems, making recommendations for DHF improvements.
    • Served on design control team providing guidance related to quality assurance.
    • Designed and conducted GMP training for plant floor and professional staff.
    • Managed calibration program for medical device company.
  • Coordinated quality objectives for medical device manufacturer of products in ostomy care, wound therapeutics, continence and critical care, and infusion devices, including:
    • Implemented procedures for compliance with 21CFR part 820.
    • Handled complaint and CAPA activities to facilitate investigations, identification of root cause and implementation of corrective and preventative actions.
    • Audited quality systems and developed global GxP audit program.
  • Managed various project initiatives for biotechnology manufacturer of drug products in neuropathology and autoimmunology, including:
    • Managed quality activities related to contract manufacturing of operations.
    • Maintained document control activities, including development of standard operating procedures (SOP), ensuring documents compliant with 21 CFR Part 210/211 regulations.
    • Handled complaints, addressing investigations, documentation of records, and corrective and preventative actions.
  • Facilitated numerous project efforts for high-profile drug, medical device, diagnostics, and consumer manufacturer of products in donor screening, immunohematology, clinical chemistry, immunodiagnostics, and wound care, including:
    • Wrote corporate quality policies, guidance documents, standard operating procedures, and work instructions for compliance with FDA and ISO regulations and guidance documents.
    • Conducted audits and provided compliance guidance to over 100 internal and contract locations related to pharmaceutical, Class I, II, and III medical device, combination product, diagnostics/biologics products.
    • Conducted pre-acquisition due diligence and/or post-acquisition quality system audits, reporting system issues to corporate and division management.
    • Developed training programs related to design controls, validation, complaint management, investigations, etc.
    • Wrote and edited global quality newsletter and FDA updates on key issues of compliance, auditing, training, and quality systems.
    • Completed Six Sigma Black Belt training and projects, and led Green Belt project personnel.
    • Led technical service personnel in quality engineering, quality improvement, complaint investigations and CAPA management.
    • Provided quality management support for scale-up location to include document approval, validation reviews, testing programs, and equipment review.
    • Managed technical service department in cost improvement projects for disposable devices.
    • Conducted product scale-up and manufacturing problem resolution in medical device plant.
  • Directed all quality assurance functions for manufacturer of $500 million consumer products division, with responsibility for 3 plants, 20 contract manufacturers and $3 million budget.
  • Developed new thermoset polymer products and resolved manufacturing and customer related problems for aerospace and electronic applications.
  • Researched new HPLC methods for drug and cancer laboratory within Yale Medical School.


  • Moran Consulting, Consultant, (Hopewell, NJ) – 2007 to Present
  • ConvaTec, Associate Director, Quality Assurance, (Skillman, NJ) – 2006 to 2007
  • Moran Consulting, Consultant, (Hopewell, NJ) – 2004 to 2006
  • Élan Pharmaceuticals Inc., Quality Assurance Manager, (Princeton, NJ) – 2003 to 2004
  • Ortho-Clinical Diagnostics, Manager of Regulatory Compliance (Raritan, NJ) – 2001 to 2003
  • Johnson & Johnson, Mgr, Tech. Assurance, Consumer Products (North Brunswick, NJ) – 1999 to 2001
  • Johnson & Johnson, Area Manager, Corporate Staff (New Brunswick, NJ) – 1990 to 1999
  • Boyle Midway (American Home Products), Director, Quality Assurance (Wayne, NJ) – 1988 to1990
  • Johnson & Johnson, QA Manager, Consumer Products (Skillman, NJ) – 1988 to 1988
  • Johnson & Johnson, Ntl. Technical Serv. Manager, Personal Products (Milltown, NJ) – 1984 to 1988
  • Johnson & Johnson, Group Leader, Technical Services (Chicago, IL) – 1978 to 1984
  • U.S. Polymeric, Research and QA Chemist (Stamford, CT) – 1973 to 1978
  • Yale Medical School, Research Chemist-HPLC (Newhaven, CT) – 1970 to 1973


  • Studies towards Master in Business Administration, University of Bridgeport – 1973 to 1977
  • Bachelor of Arts in Chemistry, University of Connecticut – 1966 to 1969


  • Certified Quality Auditor (CQA), American Society of Quality – Certified until 2006
  • Certified Quality Engineer (CQE), American Society of Quality – Certified until 2006
  • Certified Quality Manager (CQM), American Society of Quality – Certified until 2006


  • Auditing Clinical Trials/GCP, PTI International – 2004
  • Transition to ISO 9000, American Society of Quality – 2002
  • Bloodborne Pathogen Training, Ortho Clinical Diagnostics – 2002
  • Trackwise CAPA Training, Ortho Clinical Diagnostics – 2002
  • Finance for the Non-Financial Manager, Johnson & Johnson – 2000
  • Six-Sigma Black Belt Training, Johnson & Johnson – 1999
  • Microbiological Control and Compliance (Guest Lecturer), Ortho Pharmaceuticals – 1998
  • Signature of Quality (SOQ) Examiner (Malcolm Baldridge Criteria), Johnson & Johnson – 1997
  • FDA Training, Biometric Research Institute – 1996
  • Quality Systems in Pharmaceutical Industry (Guest Lecturer), Fairleigh Dickinson University – 1993
  • Certified Quality Auditor (Trainer), Johnson & Johnson – 1993
  • Lead Assessor Certification Training, Stat-A-Matrix – 1993
  • Aerosol Technology, Center for Professional Advancement – 1990
  • Action Tools for Middle Management, American Management Association – 1987
  • Implementing Juran (Quality Improvement), Juran Institute – 1987
  • Problem Analysis and Decision Making, Learning International – 1987
  • Quality Improvement Training, Johnson & Johnson Quality Institute – 1986


  • American Society for Quality (ASQ) – 1986 to 2006
  • American Chemical Society – 1969 to 2003