Frederick N Mayer

Frederick N Mayer

2401 Worthing Court

Wake Forest North Carolina (NC) 27587-4825

mayerfrederick38@gmailcom

Home919-562-5290 Cell 919-607-0500

SUMMARY OF PROFESSIONAL QUALIFICATIONS

  • Implementation and management of quality systems and audit programs
  • Extensive US and International systems audit experience(GLP/GCP/GMP, ICH, ISO, and Eudralex)
  • Proven project managementand successfulNew Drug approval
  • Prepare, manage and host FDA Systems, Pre Approval inspection(PAI) and international inspections
  • Successful start up and validation of pharmaceutical facilities
  • Author and implement GXP compliant procedures
  • Manage departmental budgets
  • Proven quality, process improvement and cost savings via lean manufacturing
  • Mentor/coach and develop staff utilizing training programs and organizational objectives
  • Strong teamwork/interpersonal skills, ability to influence all levels of management

PROFESSIONAL EXPERIENCE

CHEMISTRY FOR LIFE Inc, Wake Forest NC Aug 2008 to Present

Consultant/Contractor-Quality Systems/Compliance/Audit

Hammill Manufacturing Co., Maumee, OH

  • Warning Letter Recovery, Device Quality Systems

ADS Biotechnology, Ltd, Toledo, OH

  • Audit plan for Albumin Active Pharmaceutical Ingredient Supplier toxicology/PEG synthesis
  • Capital Investment Estimates for Sterile Isolator, toxicology/Phase I Clinical Trials

Quality Care Products LLC, Toledo, OH

Authored Physician Sample Distribution Management Policy

STIEFEL LABORATORIES Inc, Research Triangle Park, NC Nov 2006 to Aug 2008

Senior QA Compliance Manager

As a member of the QA start up team developed and implemented the site Quality Systems:

  • Document Management, Release, Deviations, CAPA, Change Control, Specifications, Trending, Analytical and Process Technical Transfer, Methods Development and facility validation
  • Established external and internal audit programs (GLP/GCP/GMP, ICH, Eudralex), perform audits
  • Mentor/train staff in audits and regulatory inspections
  • Quality Agreements,Contract Research Organizations/Clinical Trial suppliers
  • Quality assurance Lead, project management teams for new products in all phases of l development

WYETH BIOTECH, Sanford, NC Dec 2005 to Nov 2006

Associate Director, QA Compliance Auditing, Vaccines

  • Mentor/train organization personnel in audits and regulatory inspections
  • Host and manage site FDA (CBER), International regulatory inspections and corporate audits
  • Developed the annual internal and external audit plan
  • Manage electronic data management (EDMS) commitment tracking system
  • Implementation of electronic communications during inspections
  • Development and Completion of the site master file

PFIZER INC, New York City, NY 2003 to 2005

Senior Corporate Quality Assurance Manager (Research and Development)

  • Systems audits of US and International Pharmaceutical Development and Clinical Trial Suppliers
  • Pfizer Quality Practice Guidelines and applicable FDA, Eudralex, regulations and ICH, ISO, guidelines

GLAXOSMITHKLINE, RTP, NC 2001-2003

Manager, GMP Compliance, R&D World Wide Regulatory Compliance (WWRC)

  • Recognized for accomplishmentsas Validation Team Leader for GSK Warning Letter Recovery Team, Cidra Puerto Rico
  • Perform systems audits and prepare R&D laboratories, manufacturing sites and contract suppliers for FDA general inspections and Pre- Approval Inspections for new chemical entities
  • Perform Due Diligence audits of laboratories and facilities for in licensing and perspective clinical suppliers
  • Assist new WWRC organization in preparing procedures for both department and GSK guidelines on Systems based and Pre-Approval Inspections
  • Coauthored guidance document for Pre Approval Inspections, site assessments and inspection readiness

GLAXO WELLCOME INC, Zebulon, NC 1999-2001

Compliance Manager, Global Quality Assurance

  • Prepare , host and manage FDA systems and Pre- Approval Inspections
  • Global quality systems audits oforganization and contract suppliers
  • Alignment and implementation of post merger GMP quality system initiatives
  • Due Diligence

PFIZER INC, New York City, NY 1997-1999

Senior Quality Assurance Auditor

  • Global Quality Assurance audits— contract suppliers, research and Pfizer manufacturing sites
  • Pfizer Quality Practice Guidelines and applicable FDA, Eudralex, regulations and ICH, ISO, guidelines

OHMEDA, INC, Liberty Corner, NJ 1996-1997

(A Manufacturer of critical care anesthesia and small volume injectable products)

Manager of Supplier Quality

Corporate Documentation Manager

Operations Manager for Inhaled Nitric Oxide (INO) Start-Up Team, Port Allen, LA

GLAXO WELLCOME, INC, Greenville, NC 1989-1996

Validation Section Head (Solid Dose)

  • Recruitment of validation engineers
  • Technical transfer

GLAXO, INC.

Quality Assurance Manager, Zebulon, NC

  • Established Wake Technical Institute two-year Degree Program in Pharmaceutical Technology at Zebulon manufacturing site
  • Re-evaluated in-process sampling and testing program saving company over $300,000 annually
  • Quality Assurance oversight of research and commercial validation activities
  • Established Career Ladder Program
  • Developed training program (solid dose, Aerosol)
  • Established Quality Benchmarking between area pharmaceutical firms

Validation Section Head, Research Triangle Park, NC

  • Recognized for contributions in facilities Start up and validation of Pharmaceutical Development facilities & Animal Laboratories
  • Prospective validation of a broad spectrum of facility systems, equipment

AJINOMOTO USA INC, Raleigh, NC 1979-1989

(Manufacturer of parenteral/enteral grade amino acids as Active pharmaceutical Ingredients)

Purification Mixing & Packaging Manager

Fermentation Separation Manager

Materials Manager

  • Recognized for achievementsand contributions of “Grass Roots” facilities start up
  • Recruiting/hiring/training/managing and motivating 125 site personnel
  • Establishment of site quality systems
  • Validation of purification facilities (HVAC ,Purified water) systems and processing equipment
  • Reduced fermentation contamination levels from 22% to 10% in nine months, saving $900,000
  • Successfully worked within departmental budgets saving company $250,000
  • Maintained productivity with reduction in work force
  • Participated in plant energy savings program, reducing total energy budget $400,000 annually
  • Hosted and managed FDA inspections

STUART PHARMACEUTICALS (Astra Zeneca), Newark, DE

Quality Assurance Supervisor

ABBOTT LABORATORIES (Hospira), Rocky Mount, NC

Quality Assurance Supervisor

PALL BIOMEDICAL CORPORATION, Glen Cove, NY

Microbiologist

EDUCATION AND TRAINING

Bachelor of Science in Biology, Minor Chemistry

UNIVERSITY OF MIAMI, Coral Gables, FL

Adelphi University, Long Island, NY

Graduate Courses in Business Management / Biostatistics / Microeconomics

Management Foundations of Leadership Program, GlaxoSmithKline

Certified ISO 9002 Lead Auditor

PDA Aseptic Processing

Device Quality Systems Inspection Technique (QSIT)

Negotiating with FDA

Systems and Process Based Auditing (Pfizer/ASQC)

Good Laboratory Practices (FDA and EPA)

UNC Office of Clinical Trials

  • FDA GCP Inspections
  • Good Clinical Practice
  • Advanced Good Clinical Practice
  • Dissecting a GCP Protocol

PROFESSIONAL AFFILIATIONS

Parenteral Drug Association

International Society for Pharmaceutical Engineering