Kathleen Brady, Associate Director, QA, ImaginAb

Accomplished member of Regulatory Affairs and Quality unit with 20+ years combined experience in Regulatory Affairs, Quality Control and Quality Assurance in the pharmaceutical industry. BS degree in Chemistry and Master’s Degree in Business Administration with concentration in Management and Leadership. Experienced in cGMP setting, FDA 21 CFR, GLP, ICH, EU GMP, regulatory submission, stability program, investigations, analyzing quality issues, designing improvement, developing plan for corrective and preventative measures (CAPA), monitoring compliance, statistical analysis, product profiling, developing policies/procedures, auditing suppliers, and managing QMS.

• Regulatory submission
• Hosting audits
• Auditing suppliers
• Strong problem solving skills
• Managing QMS

ADDITIONAL RELEVANT EXPERIENCES:

USP (US PHARMACOPEIAL CONVENTION)

Baltimore, Maryland

Good Documentation Guidelines Expert Panel

PITTCON

Philadelphia, Pennsylvania

Short Course Instructor

ILLINOIS INSTITUTE OF TECHNOLOGY

Guest Lecturer

CERTIFICATION:

Certified Quality Auditor by American Society for Quality (ASQ)