With over 25 years of clinical quality and compliance experience, Maryrose Petrizzo has demonstrated her expertise across various remote and on-site roles within emerging and established companies. She boasts a comprehensive skill set that includes quality oversight of drug, biologic, and medical device clinical trials; regulatory inspection readiness; quality systems development and implementation; risk, record, and issue management; clinical due diligence; pharmacovigilance; and Good Clinical Practices (GCP).
In addition to establishing / managing clinical inspection readiness programs for FDA, EMA, and MHRA regulatory agency inspections, Maryrose has consulted for NIH / NIAID / DAIDS. Her expertise encompasses multiple therapeutic areas, including CNS, cardiology, neurology, gastroenterology, oncology, blood products, plasma, and rare diseases.
Equipped with Cyntegrity Black Belt training in Risk-Based Quality Management, Maryrose offers a range of training services covering ICH E6 GCP, ISO 14155:2020, inspection readiness, mock inspection conduct, Subject Matter Expert interviews, protocol deviation management, sponsor oversight, and clinical trial risk management.