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