Paul J. Moran

Consultant

• (610) 462-4090
• info@qualitysolutionsnow.com

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.

CORE COMPETENCIES

• 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

SELECTED ACCOMPLISHMENTS

• 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.

PROFESSIONAL EXPERIENCE

• 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

EDUCATION

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

CERTIFICATION

• 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

TRAINING

• 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

AFFILIATIONS

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