Gena Wolfe

Gena Wolfe is a Regulatory Manager at Baxter International Inc., where they manage site CAPA programs and assure global regulatory compliance of IT solutions as medical devices. With over 20 years of experience in the pharmaceutical industry, Gena has held various roles, including Regulatory Compliance Strategist at Cerner Corporation and Quality Engineer at 3M, focusing on quality assurance and regulatory strategies. Gena earned a Master of Science in Business Management from Baker University and a Bachelor of Science in Biology from Central Missouri State University. Throughout their career, Gena has led numerous quality initiatives and audits, demonstrating a strong commitment to regulatory compliance and quality improvement in medical device manufacturing.