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Kathleen Magliere Zajd, CQA, Senior Vice President, Regulatory Operations and Compliance, oversees Prologue’s compliance and quality management program. Primary responsibilities include Standard Operating Procedures (SOP) management, SOP and Good Clinical Practice (GCP) training, process and project-directed audits, compliance consulting, quality assurance activities, and implementation of continuous process improvement plans. Ms. Zajd has over 25 years of oncology pharmaceutical research experience and is a certified quality auditor. Prologue’s clients benefit from her extensive knowledge of FDA regulations and operational processes for conducting research on drugs, biologics, and medical devices to ensure that they comply with GCPs, Good Laboratory Practices (GLPs) and 21CFR Part 11. Ms. Zajd has a great deal of experience with conducting both domestic and international audit programs. She has also served as company liaison for many FDA inspections in the U.S. and abroad. From 1980 to 1996, Ms. Zajd held various research and regulatory compliance positions with Adria/Pharmacia & Upjohn. She eventually was responsible for directing the company's GCP, GLP compliance program (for drugs, devices, and biologics), complaint handling, and medical device tracking. Following the merger between Pharmacia & Upjohn, Ms. Zajd joined the Hardardt Group, a CRO, as their manager of quality assurance. Before joining Prologue in 1998, Ms. Zajd served as compliance manager/ pharmacovigilance officer for the Neoprobe Corporation. She was responsible for ensuring regulatory compliance to GCPs and GLPs, overseeing the company's standard operating procedures, managing the quality audit program, and handling the post-market safety reporting. In addition, Ms. Zajd established initial and ongoing training programs for both employees and contract personnel.
Ms. Zajd has provided services as a consultant in numerous corporate and academic environments, in all areas of regulatory compliance. Ms. Zajd is a member of the American Society for Quality, Society of Quality Assurance, Regulatory Affairs Professionals Society, Association of Clinical Research Professionals, and the Drug Information Association. | 