Ms Karen M. Migliaccio
BSChem, MS, Analytical - Chemistry
- + 1 857 277 0060
Karen is an analytical chemist and has over 30 years’ experience in the pharmaceutical industry. She worked for Pfizer, Inc. in a series of progressively more responsible positions in Quality Assurance and Control functions. She has worked in technical, supervisory and management positions in both commercial and R&D quality functions. Most recently, Karen held the position of Senior Director, Quality Operations, at Pfizer’s Groton, CT R&D site.
Karen has extensive knowledge of GMP requirements, regulatory inspections, and Quality Systems development and implementation. She has a working knowledge of the drug development process, regulatory filing, and product launch. She has provided Quality oversight for diverse manufacturing processes, including API, drug product intermediates, clinical supplies manufacturing and packaging, and a variety of drug product formulations.
As an independent consultant, Karen works with clients on a variety of projects, including FDA pre-approval inspections, root cause analysis, auditing and Quality Systems.