Angela Haag
About Angela Haag
Angela Haag serves as the Acting Quality Director at the Center for Cellular Engineering at the National Institutes of Health. She has extensive experience in quality management and regulatory affairs, having worked with major pharmaceutical companies and possesses a strong background in coordinating submissions for various drug applications.
Work at National Institutes of Health
Angela Haag serves as the Acting Quality Director at the Center for Cellular Engineering at the National Institutes of Health (NIH) in Bethesda, MD. She has held this position since 2018, contributing to the organization's mission of advancing biomedical research. In her role, she focuses on quality systems and compliance within the cellular engineering domain.
Previous Experience in Pharmaceutical Industry
Angela Haag has extensive experience in the pharmaceutical industry, having worked in various roles at notable companies. She was a Global Quality Manager at GlaxoSmithKline Pharma GmbH from 2006 to 2009, and prior to that, she held positions at Merck, including Manufacturing Supervisor and Research Chemist. Her tenure at GlaxoSmithKline also included a role as Sr. Regulatory Affairs Manager from 2009 to 2014.
Education and Expertise
Angela Haag earned her Bachelor of Science in Biology from the University at Buffalo, where she studied from 1984 to 1989. She later obtained a Master of Science in Natural Sciences with a focus on Pharmacology from the same institution, completing her studies from 1990 to 1992. Her educational background supports her expertise in quality system remediation and regulatory compliance.
Regulatory Affairs and Quality Management Skills
Angela Haag possesses global experience in managing products and facilities across multiple international regulatory bodies, including the FDA, KFDA, EMA, ANVISA, and Health Canada. She specializes in Chemistry, Manufacturing, and Controls (CMC) submissions for various applications, including Biologics License Applications (BLAs) and New Drug Applications (NDAs). Her skills extend to conducting risk assessments, auditing, and inspection readiness.
Validation Processes and Technical Proficiency
Angela Haag has expertise in a wide range of validation processes, including assay validation, process and equipment validation, and cleaning validation. She is proficient in using various computer applications such as LIMs, SAP, Trackwise, Minitab, JMP, and Documentum, which enhance her ability to manage quality systems effectively.