Sereen is a highly accomplished clinical compliance executive and former FDA BIMO Investigator with over 14 years of progressive quality assurance expertise spanning clinical and non-clinical research, GCP compliance, and international regulatory oversight. She holds a Master of Science in Clinical Research Management (Regulatory Science) from Arizona State University and a Level 1 Investigator Certification from the U.S. Food and Drug Administration, alongside specialized training in Drug Safety and Pharmacovigilance.

At exFDA Consultants, Sereen serves as a premier authority on Bioresearch Monitoring and clinical quality systems. Leveraging her deep institutional knowledge, she specializes in designing and managing cost-effective, risk-based compliance programs, conducting system-wide gap analyses against ICH GCP E6 guidelines, and performing comprehensive root-cause investigations. Her primary expertise includes training and leading cross-functional teams through mock regulatory inspections, authoring robust Standard Operating Procedures (SOPs), and engineering defensive CAPA strategies to resolve complex compliance challenges before they escalate.

Sereen’s exceptional field credibility is rooted in her six-year tenure as an FDA Consumer Safety Officer within the Bioresearch Monitoring division. In this role, she independently planned and executed high-priority, domestic, and international inspections. Her regulatory inspections covered New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and New Animal Drug Applications (NADAs) across Sponsors, Contract Research Organizations (CROs), Principal Investigators, and Bioequivalence laboratories. Her enforcement experience includes authoring formal Establishment Inspection Reports (EIRs) and driving regulatory actions against non-compliant entities.

Following her distinguished tenure at the FDA, Sereen held senior global leadership positions in the private sector, serving as Senior Manager of Clinical Quality Assurance at Idorsia Pharmaceuticals and Senior Manager of Clinical Compliance at Seagen. Combined with her early scientific background managing clinical pathology compliance for the National Institutes of Health (NIH) and National Cancer Institute (NCI), Sereen provides exFDA clients with an unmatched, authoritative perspective on human subject protection, study data integrity, and total audit readiness.