Modernizing Quality in Your Manufacturing Operations

Director, Strategy, QualityOne

As director of strategy for QualityOne, Sophia is the team’s resident quality subject matter expert and is responsible for developing thought leadership content, industry influence strategies, and sales and marketing collateral to drive brand awareness and product adoption. Sophia brings to the team over 10 years of direct quality experience in regulated industries.

She began her career with the FDA working in CBER’s vaccine lot release program and later moved to the FDA’s office of regulatory affairs as a regulatory microbiologist. Additionally, Sophia has managed CAPA, complaints, audit, and deviation programs in the medical device industry.

Sophia has a master of science in bioscience in regulatory affairs from Johns Hopkins University and is an ASQ Certified Quality Auditor.

Sr. Solutions Consultant

Solution Consultant

Solution Consultant

Senior Partner & Managing Director
Kearney

Michael Roemer is a senior Partner & Managing Director at Kearney. He leads the Global & EMEA Digital Transformation practice. In 2015 Michael founded the Kearney Digital Lab. He works on accounts in the consumer and retail industry and the automotive industry where he has a key account management role. His functional focus includes sales and marketing, supply chain management and information management.