Elizabeth Leininger, Ph.D.
About Elizabeth Leininger, Ph.D.
Title
Elizabeth Leininger serves as the Vice President of Regulatory Affairs and Quality. In this role, she oversees regulatory strategies, compliance, and quality assurance systems for the organization. Her responsibilities include ensuring that the company meets all regulatory standards and remains compliant with industry regulations.
Education and Expertise
Elizabeth Leininger earned her Ph.D. in chemistry from the University of North Carolina at Chapel Hill. She possesses significant expertise in global strategic development, licensing, and post-marketing regulatory activities, specifically for biological and biotechnology products. Her academic background provides a strong foundation for her role in regulatory affairs and quality assurance.
Professional Background
Prior to her current position, Elizabeth Leininger held senior management roles at Chiron, which was later acquired by Novartis, and at GSK. These positions allowed her to gain extensive experience in regulatory affairs and quality management, applying her knowledge to oversee large QA/QC organizations.
Regulatory and Quality Initiatives
Elizabeth Leininger has run large QA/QC organizations where she was responsible for the evaluation, development, and implementation of quality systems. Her initiatives included comprehensive documentation, training programs, and auditing processes. These efforts ensured that her teams adhered to stringent quality standards and continuous improvement practices.