Karrie Hilsinger
Founder | Inspection Readiness & Compliance Consultant
With over two decades of experience in the pharmaceutical and biotech industry, Karrie Hilsinger is a trusted expert in inspection readiness and regulatory compliance. Throughout her career, she has supported a wide range of organizations—large and small—through complex regulatory inspections and comprehensive inspection readiness initiatives.
Karrie's journey began with a simple but powerful idea: that quality and compliance should be seamlessly integrated into the fabric of clinical operations. Driven by a deep passion for these principles, she has built a consulting practice dedicated to helping companies achieve and sustain a state of true inspection readiness.
Having worked directly on inspections led by multiple global regulatory authorities, Karrie brings a realistic, solutions-oriented perspective to the challenges teams face. Her firsthand experience enables her to provide personalized, detail-focused guidance that empowers teams to meet regulatory expectations with clarity and confidence.
Today, Karrie partners with sponsor organizations and clinical teams to elevate their preparedness, reduce risk, and build a culture of continuous quality. Her mission remains clear: to make inspection readiness not just a milestone, but a mindset.
