Mary Climo

Mary Climo has a diverse range of work experience in quality assurance and compliance management roles.

Their most recent position is as the Director of QA at Gallant, where they ensure regulatory compliance and maintains the Quality Management System (QMS). Mary also oversees manufacturing processes, materials, equipment, quality audit programs, training, clinical activities, inspection readiness, and corrective and preventive action systems.

Prior to their role at Gallant, Mary worked at MEI Pharma in various positions. As the Associate Director of GMP Quality Compliance, they managed external and internal audits related to Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs). Mary also supervised the evaluation and selection of external consultants for audits. In their role as Sr. Manager of GMP Quality Compliance, Mary was responsible for compliance programs and conducted internal and external audits. Mary ensured adherence to FDA, EMA, PMDA regulations and ICH guidelines applicable to GCP, GDP, and GMPs. Additionally, as Sr. Manager of Quality Systems, they maintained and executed systems and processes for GxP compliance, including Clinical Trials.

Before joining MEI Pharma, Mary worked at Teva Pharmaceuticals as the Sr. Manager of Corporate Internal Audits Global Inspections & Audits. In this role, they served as a Lead Auditor, overseeing compliance to GxP, including serialization and data integrity. Mary managed a team of auditors and successfully integrated systems during a company buyout.

Mary's earlier experience includes working at Allergan as a Corporate Compliance Manager, where they trained auditors, reviewed systems and documentation, and developed and implemented a corporate auditing program for GxP compliance. Mary also worked at CoCensys as the Associate Director of Quality Assurance & Regulatory Affairs, where they initiated and approved standard operating procedures and audited various organizations and data sources related to clinical trials.

Mary's career began at Alcon - Steri-Oss - Beckman Instruments in a Quality Assurance role.

Overall, Mary Climo has extensive experience in quality assurance, compliance management, and auditing in the pharmaceutical industry.

Mary Climo attended California State Fullerton and Cypress College, both located in Cypress, CA. However, the information provided does not mention the start and end years, the degree obtained, or the field of study pursued.