Auditor is a seasoned professional with over two decades of expertise in FDA-regulated medical product research, quality assurance, and regulatory compliance. Currently serving as Senior Director of GCP Quality Assurance at Stealth Biotherapeutics, she leads the implementation of risk-based quality strategies for clinical trials, ensuring adherence to FDA regulations. She has previously held key roles, including Director of Clinical Quality Assurance at Spectrum Pharmaceuticals and Associate Director at IQVIA, where she excelled in inspection readiness and audit leadership. Her distinguished FDA career involved roles as a Senior Regulatory Health Project Manager and Investigator, earning prestigious awards. Her skills extend to medical writing and laboratory work. With academic qualifications in Microbiology and Endocrinology, as well as certifications in quality and auditing, she is a highly accomplished professional in the pharmaceutical and regulatory industry.