Bluegrass Biggs

About Bluegrass Biggs

Grounded in a blend of innovation and hands-on experience, my professional ethos is informed by a multidisciplinary skill set—ranging from regulatory compliance and program management to data science and technology. Rather than accepting the status quo, I\'m driven by an entrepreneurial spirit that constantly seeks to challenge and optimize. My passion for problem-solving propels me to identify areas of inefficiency, waste, or stagnation. By partnering with like-minded individuals, I focus on crafting innovative solutions, particularly within the Life Sciences sector. My dual aims when founding companies or developing solutions are straightforward: firstly, to cultivate a workplace that thrives on freedom and creativity; and secondly, to relentlessly pursue better methods and processes. In my quest for delivering cutting-edge project management and regulatory compliance solutions, I consider every team member crucial in both ideating and executing our strategies. My approach to success hinges on authenticity—eschewing pretense and flash in favor of ambitious, practical thinking. Specialties: My expertise spans Project Management, Portfolio Management, Quality Systems Development and implementation, Computer System Validation (CSV), compliance with 21 CFR Part 11, Continuous Validation, Laboratory Equipment Qualification, and Vendor/Supplier Audits in FDA, CLIA, EMEA-regulated settings, as well as GDPR and HIPAA compliance.

Experience

1. Founding Team Member and Leader of Technology and Compliance

   Rabble Health

   Apr 2020 — Present · Thousand Oaks, CA, US

Education

• University of Oregon

  Bachelor's degree, Biochemistry

  1992 — 1994