Nichole has over 20 years of experience in small molecule manufacturing from development through commercialization with proven track record of implementing and overseeing quality management systems and driving continuous improvement initiatives to enhance product/process quality and operational efficiency.
She held positions of increasing responsibility at various CDMO pharmaceutical companies based in the US. She has successfully led and facilitated regulatory authority inspections while ensuring quality management systems are in place, in use, and effectively monitored to facilitate compliance with CGMP requirements.
Nichole is responsible for the Quality Systems, Project Quality Assurance, and Quality Control functions at the Philadelphia sites.