About Evgeniya

Evgeniya leads quality-compliance and remediation work for medical-device companies. She has extensive experience in remediating quality-compliance crises and transforming quality systems, operations, and culture.

Recent examples of her work include the following:

  • 15-month multisite quality-compliance remediation effort that involved optimizing remediation scope and plan, establishing a project-management office of 600+ contractors, eliminating a 12-month delay, and delivering remediation on time with a 20% saving with no FDA observations in follow-up
  • 5-month remediation and successful restart of a pharmaceutical-manufacturing site after a shutdown due to quality-compliance issues
  • A quality-transformation program for a medical-device company from initial benchmarking and compliance assessment through a series of process transformations for key quality systems (for example, complaint management, corrective and preventive action, risk management, quality-management review, change controls)
  • A quality organization redesign for a health sector of a major medical-products company that achieved 30-plus % efficiency in 4 years
  • Optimization of approval processes and increase of in-market product quality for a leading regulator

Published work

Manufacturing quality today: Higher quality output, lower cost of quality,” McKinsey & Company, September 2017

Capturing the value of good quality in medical devices,” McKinsey & Company, February 2017

Past experience

KPMG (Germany)
Auditor and Supervisor

Ekosem-Agrar (Russia)
CFO

Education

University of Chicago, Booth School of Business
MBA, strategic management

Kostroma State Agricultural Academy, Russia
BSc, economics