Summary:

Professional quality assurance and quality control manager with over 30 years experience managing quality system programs for a multinational company. Proven skills in auditing quality systems for compliance to ISO 9000 and drug/device cGMP's. Developed industry leading programs related to process validation, change control, change management, CAPA, and the resolution of customer complaints. Experienced in conducting and managing FDA and customer audits. A customer focused professional who uses a practical, innovative and analytical approach to problem solving.

Professional Experience:

REPLIGEN CORPORATION, WALTHAM, MASSACHUSETTS

Quality Systems Consultant (2010 - 2012)

Provided consulting services on Quality System projects including the development and introduction of new Bioprocessing products.

REPLIGEN CORPORATION, WALTHAM, MASSACHUSETTS

Director of Quality (2006 - 2009)

Responsible for directing Repligen's Quality Assurance and Quality Control functions and developing a formal quality management system.

MILLIPORE CORPORATION, BEDFORD MASSACHUSETTS (1976 - December 2003)

Manager, Quality Systems Programs (1994 - 2003)

Responsible for creating and managing Millipore's BioProcess Quality Systems Department. Managed 12 quality professionals and the division's worldwide quality programs.

Manager, Customer Certification Program (1991 - 1994)

Responsible for creating and managing a worldwide Customer Certification Program for Millipore.

Manager, Quality Assurance, Jaffrey New Hampshire Operations (1988 - 1991)

Responsible for managing the quality function for Millipore's largest manufacturing facility. Managed a department of 30 QA/QC employees in a high technology laboratory environment.

Manager, Quality Assurance, MPD Division (1980 - 1984)

Responsible for managing the quality assurance function for Millipore's MPD Division. Managed a group of 4 quality professionals.

Director, Corporate Quality Engineering (1976 - 1980)

Responsible for creating and managing a quality engineering department for Millipore's corporate headquarters. Successfully met the charter for the department which was to establish and maintain compliance with FDA Medical Device cGMP regulations. Managed a group of 14 quality engineering professionals.

WORTHINGTON BIOCHEMICAL CORPORATION, FREEHOLD, NEW JERSEY (1969 - 1976)

Director, Quality Assurance & Regulatory Affairs

Established a quality assurance and regulatory affairs function to address FDA, EPA and OSHA issues.

MICHIGAN STATE UNIVERSITY, EAST LANSING MICHIGAN (1967 - 1969)

Teaching Assistant in Biochemistry

 

Education:

B.A. Lake Forest College
Lake Forest, Illinois
Major: Chemistry

M.S. Michigan State University
East Lansing, Michigan
Major: Biochemistry

Awards & Recognitions:

Navy Science Cruiser Award
Greater Newark Science Fair

First Place; Biological Sciences
Greater Newark Science Fair

Alumni Award For Excellence In Chemistry
Lake Forest College

Honors in Chemistry/Senior Thesis
Lake Forest College

Best Written Technical Paper
National ASQC Congress, Chicago, Illinois

Publications:

"RAT BRAIN HEXOKINASE: A KINETIC COMPARISON OF SOLUBLE AND PARTICULATE FORMS." Thesis for the Degree of M.S., Michigan State University, 1969.

"ACE: A system that Improves Quality and Profits." Quality Progress Magazine, February 1985

"Computer Aided Quality", ASQC National Congress, Minneapolis, Minnesota, 1987.

"Pilot Production Quality Assurance", ASQC National Congress, Minneapolis, Minnesota, 1989.

"Change Management in the Pharmaceutical Industry", Pharmaceutical Engineering, 22, (5), 2002, PP 8-18.

Memberships:

American Chemical Society

American Society for Quality Control

Parenteral Drug Association

International Society for Pharmaceutical Engineering