With over 28 years of experience in quality assurance and quality operations in the pharmaceutical and biotechnology industries, I am a passionate leader who strives to ensure the highest standards of quality and compliance for the development of innovative therapies for patients with CNS diseases, chronic respiratory diseases, severe rare diseases and cancer. In my various roles I have been responsible for all quality aspects of manufacturing, testing, and release of gene therapy, oncology solid dose, and inhalation products. I also have deep involvement in clinical trial start up and quality oversight of all vendors and sites with emphasis on Quality Risk Management. I collaborate with cross-functional teams to establish and maintain quality systems and processes. I have strong laboratory skills, extensive knowledge of pharmaceutical regulations and guidelines, and proven ability to conduct effective internal audits and implement continuous improvement initiatives. I am motivated by the mission of delivering life-changing treatments to patients with unmet medical needs, and I value teamwork, integrity, and excellence in my work.