Chris Lee

About Chris Lee

An innovative and creative biopharma / tech business leader. Leadership perspective grounded in driving the evolution of regulatory / safety / clinical to an innovative, enterprise, compliant and cost-efficient capability through the use of digital, external business partners, and sound business principals. Interested in connecting with visionary individuals and companies that see beyond the limitations of physical location to drive effective organizations through talent acquisition unbound by geography.Professional with over 25 years of diverse experience with strong leadership, innovation, business, operational excellence, organizational management, compliance, quality systems, organizational change management, regulatory affairs, clinical operations, safety, pharmacovigilance, information technology, and project management expertise. Experience in building scalable operational and quality platforms and leading global teams located in Asia, Europe and North/South America. Experience establishing offshore captive and non-captive (BPO) shared services capabilities in low-cost geographies including India, China, Poland, Colombia, Philippines and Mexico.

Experience

1. Advisory Board Member

   Weave Bio

   Dec 2025 — Present · Missoula, MT, US

   Serve on Advisory Board of Weave.bio. Weave\'s mission is to equip human experts with the AI tools they need to develop faster, safer and more affordable treatments for patients. Through regulatory innovation and scientific collaboration, we’re transforming how life-saving therapies reach the people who need them.

Education

• University of Liverpool

  Master of Public Health (MPH), Public Health

• Azusa Pacific University

  MS, Computer Science

• California State University-Dominguez Hills

  MPA, Public Administration

• California State University-Dominguez Hills

  Bachelor of Science (BS), Public Administration

• Roosevelt High School

  High School Diploma

Skills

• Biotechnology
• Change Control
• Pharmacovigilance
• Gmp
• Process Improvement
• Medical Devices
• Clinical Research
• Capa
• Ctms
• Clinical Trials
• Pharmaceutical Industry
• Sop
• Fda
• 21 Cfr Part 11
• Drug Development
• Gcp
• Biopharmaceuticals
• Life Sciences
• Clinical Development
• Regulatory Affairs
• Lifesciences
• Regulatory Submissions
• Cross-Functional Team Leadership
• Vendor Management
• Leadership
• Oncology
• CRO
• Commercialization
• Regulatory Requirements
• Ind
• Standard Operating Procedure (Sop)
• Strategy
• Program Management
• Quality Management
• Project Management
• Validation