James Emling
Greater Milwaukee,United States
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James (Jim) Emling is a highly accomplished executive with extensive experience in quality assurance and regulatory affairs within the pharmaceutical, biotechnology, and medical device industries. He currently serves as the Chief Quality Officer at Exact Sciences, where he is responsible for overseeing all aspects of the company's quality management system, ensuring compliance with global regulatory requirements, and driving a culture of quality excellence. Prior to Exact Sciences, Jim held significant leadership roles at major healthcare companies including Baxter International and Merck, where he demonstrated a strong track record in enhancing quality systems, managing inspections, and ensuring product safety and efficacy. His expertise encompasses global quality operations, GMP (Good Manufacturing Practices), and strategic quality leadership.
Professional Summary
James Emling's work history includes a series of influential roles in various companies. Here is a detailed list of his professional journey:
Notable Achievements
Chief Quality Officer at Exact Sciences
Leads the global quality and regulatory compliance strategy for a leading cancer diagnostics company, ensuring the highest standards for products like Cologuard® and Oncotype DX®.
VP, Quality at Baxter International
Oversaw quality for significant segments of Baxter's global operations, implementing improvements and ensuring adherence to stringent regulatory standards in the medical device and pharmaceutical sectors.
Executive Director, Quality Operations at Merck
Held escalating roles of responsibility in quality assurance at Merck, contributing to the quality oversight of a diverse portfolio of pharmaceutical products and manufacturing sites.
Expertise in FDA and Global Regulatory Compliance
Successfully navigated complex regulatory landscapes, managing FDA inspections and ensuring compliance with international quality standards throughout his career.
Educational Background
Bachelor's degree, Computer Science and Accounting
University of Wisconsin-Madison - Year 1993
MBA, Management
Marquette University - Year 1999
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Company Overview
DatassentialDatassential is a leading food and beverage insights platform, providing data, analytics, and market research to help businesses understand food trends, consumer preferences, and operator behavior. They empower foodservice companies, suppliers, and distributors to make smarter strategic decisions through comprehensive reports, software solutions, and custom research, covering aspects like menu development, new product innovation, and market entry strategies.
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