Malka Fraiman

Malka is a specialist master in Deloitte & Touche LLP's Enterprise Operations & Risk practice serving as a subject matter specialist on life sciences quality and regulatory processes. Malka has been with Deloitte since April 2020 and has more than 25 years of experience in life medical devices, In Vitro Diagnostics (IVD), and pharma processes - specifically in the regulatory and quality space. Prior to Deloitte, Malka worked 16 years in the life sciences industry and has experience in a wide range of quality and regulatory processes including but not limited to: applying new and existing regulations to meet compliance requirements, audits and inspection management, risk management, change management, and improving compliance in quality and regulatory processes. She is experienced in regulatory & quality process mappings, quality systems compliance, gap analysis and remediation, regulatory body and internal audit preparation, execution, and remediation.

In industry, Malka led 5 departments of >30 staff members in several locations worldwide which focused on case processing/complaint handling, CAPA (Corrective and Preventive Action), quality, manufacturing compliance, IPT (In Process Testing), product release, internal audits and inspections, GcP (Good Clinical Practice) and supplier qualification. She introduced new processes to handle risk management of adverse events (complaints, CAPA and OOS (Out of Specification)), established interconnected workflows, operating budgets, and a laboratory function, all to comply with regulatory standards. She managed +$7M department budgets, participated in >10 successful product launches and pre-approval U.S. Food and Drug Administration (FDA) inspections, and quality process improvement initiatives.