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Carolyn Gillespie

Carolyn Gillespie

Scientific Specialty:
Chemistry, Pharmacogenetics, Toxicology

Domain Specialty:
Clinical Research, Training, Quality, Regulatory, Compliance, CLIA

Technical Expertise:
Quality Assurance, Quality Control, Procedure development

United States of America


Carolyn is a detail-oriented certified quality leader with extensive project management experience, providing leadership, innovation, and direction for start-up, large-scale and global initiatives. She is skilled in numerous specialties, including quality management systems (QMS), laboratory start-up, validation, SOP writing, documentation control, training, chemistry, biotechnology, regulatory compliance, auditing, safety, and pharmacogenetics.

Carolyn received her Bachelor of Science (B.S.) in Chemistry from Rider University, then completed her education at Northwestern University with a Master of Science (M.S.) in Chemistry. Since then, she has used her experience to develop quality systems, obtain laboratory accreditation, and ensure regulatory compliance in the analysis of clinical samples and the manufacture and testing of pharmaceutical products, medical devices, and IVDs. She is a Certified Manager of Quality/Organizational Excellence through ASQ and has worked in quality and compliance for a variety of both small and global companies including Othram, Elite Surgical Affiliates, ApoCell, Cyberonics, Abbott, and Pfizer. 

Challenges I Can Help You With

  • Laboratory Start-up
  • Quality Management Systems
  • CAPA systems and documentation
  • SOP writing
  • Validation
  • Quality control
  • Training

Work Experience

Quality Director, Othram, 2018-2020

Director of Regulatory Compliance, Elite Surgical Affiliates, 2015-2018

Director of Quality Assurance, Manager of Quality Assurance, ApoCell, 2008-2015

Quality Assurance Manager, Cyberonics, 2006-2007

Quality Assurance Project Manager, Abbott Laboratories, 2003-2006

Quality Assurance Consultant, Pfizer, 2001-2003

Director of Quality Assurance, Quality Assurance Manager, Analytical Chemist, Regis Technologies, 1989-2001


Certified Manager of Quality/Organizational Excellence (ASQ)

Master of Science, Chemistry, Northwestern University

Bachelor of Science, Rider University