Margaret Galazka
About Margaret Galazka
Margaret Galazka is the Compliance Lead at Bristol-Myers Squibb in New Brunswick, NJ, with extensive expertise in GMP guidelines and biologics quality regulations.
Current Role at Bristol-Myers Squibb
Margaret Galazka currently serves as the Compliance Lead at Bristol-Myers Squibb in New Brunswick, NJ. In this role, she oversees compliance activities, ensuring adherence to both internal standards and external regulatory requirements. Her work focuses on maintaining the highest quality in biologics products, particularly through rigorous quality reviews and regulatory submissions.
Previous Positions at Bristol-Myers Squibb
Margaret Galazka has held various positions at Bristol-Myers Squibb, showcasing her strong background in quality and compliance. From 2014 to 2016, she was the Manager of Biologics Analytical Compliance in New Brunswick, NJ. Before that, she served as the Manager of Biologics Development Quality Operations from 2011 to 2014 in Pennington, NJ. Her initial role at the company was as a Scientist II in BPPD – Analytical Development & Testing from 2010 to 2011, also in Pennington, NJ.
Early Career at Medarex, Inc.
Before her long-standing tenure at Bristol-Myers Squibb, Margaret Galazka worked at Medarex, Inc., a wholly-owned subsidiary of Bristol-Myers Squibb. From 2008 to 2010, she held the position of Scientist I, QC Validation in Bloomsbury, NJ. This role involved validating quality control processes and contributed significantly to her expertise in compliance and quality assurance.
Educational Background
Margaret Galazka obtained her Ph.D. at Seton Hall University, where she studied from 1994 to 1999. She also earned her B.S. from the same institution, studying from 1990 to 1994. Her academic background laid a solid foundation for her expertise in quality assurance and compliance in the pharmaceutical industry.
Expertise in Regulatory Compliance
Margaret Galazka brings extensive expertise in Good Manufacturing Practice (GMP) guidelines and regulations from various international bodies, including ICH, USP, EP, and JP. She possesses an in-depth understanding of FDA and EMA regulations related to the quality of biologics products. Her skills include exceptional quality review of technical documents and regulatory chemistry, manufacturing, and controls (CMC) submissions such as CTA/IND and BLA. Additionally, she is proficient at solving complex problems and providing guidance on technical and compliance decisions.