Kirsten Flanagan
CEO Owner @Statera Consulting Healthcare It Consulting
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WORK HISTORY
CEO Owner @Statera Consulting Healthcare It Consulting
CA, US
EDUCATION
University of the Pacific - Eberhardt School of Business
BS, Business Administration (Marketing)
SKILLS
ABOUT KIRSTEN FLANAGAN
I bring 20+ years of experience at the intersection of biotechnology, life sciences, IT, and regulated environments, partnering with industry leaders to deliver mission-critical projects, solutions, and process improvements.As Managing Partner & CEO of Statera Consulting, I lead a team of seasoned professionals who help biotech and pharmaceutical companies turn strategic vision into operational success. We specialize in guiding complex technology initiatives, project and program management, process design and improvement, validation support, and regulatory compliance, including risk-based approaches aligned with modern standards like FDA Computer Software Assurance (CSA). Over the course of my career, I’ve supported organizations — from clinical-stage startups to global pharma — with initiatives that improve operational performance, strengthen governance, and enable innovation while ensuring quality and compliance in regulated settings. I’m adept at aligning technology with business goals, optimizing cross-functional execution, and elevating organizational capability in highly technical and regulated domains. I help organizations implement technology and process improvements that are not only effective, but defensible in regulated environments.
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