Evgeniya Makarova

About Evgeniya

Evgeniya specializes in transforming operations and improving quality and compliance for medical-device, pharmaceutical, and consumer companies. She is passionate about helping companies make medical and consumer products safer and more reliable while also making their operations more efficient.

She has deep expertise across many strategic, operational and transformational issues for a wide variety of medical devices, pharmaceutical modalities (both human and animal health), foods, personal care, and other consumer products. This includes performing benchmarking and diagnostics; setting up supply-chain and manufacturing strategies; planning and implementing transformational change; leading process, organizational, and cultural improvements; and setting up and leading the execution of complex quality, compliance, and remediation projects.

Following are examples of her recent client work:

• overseeing manufacturing, quality, and compliance diagnostics—including operational-performance assessments, culture, and management-oversight analyses—and establishing improvement plans for pharmaceutical, animal health, and consumer-product manufacturers
• developing long- and short-term operational strategy—including manufacturing network, sourcing, capital investments, quality, and human resources—for biologics, vaccines, and small-molecule pharmaceutical operations
• leading manufacturing- and quality-performance transformation—including implementing process improvements, leveraging automation, selective outsourcing, and advanced analytics—for generic pharmaceuticals, consumer, and medical-product clients
• directing organizational design and improvement efforts for supply-chain, quality, and regulatory affairs to achieve the next frontier of quality, performance, and efficiency aspirations for medical-device, pharmaceuticals, and consumer-health companies
• leading diagnostics; planning; and quality, compliance, and remediation for leading medical-device and pharma manufacturers, including the restart of a facilities shutdown due to significant quality and compliance issues
• developing a comprehensive internal action plan to promote adoption of quality best practices for a major US regulator
• convening semi-annual medical-device quality round tables with chief quality officers of large and small medical-device manufacturers and the Food and Drug Administration, collaborating with the industry on designing and promoting quality practices

Evgeniya is a native Russian speaker and is also fluent in English and German.