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Quality Consultants that Move with You

Quality Consultants that Move with You

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Dawn Speidel, MS

Partner, GxP Quality Expert

Dawn brings 20+ years of global GMP leader with deep experience across vaccines, biologics, and advanced therapeutics. Dawn has built and led high‑performing Quality organizations, served as VP of Quality & Validation, and published in BioProcess International. She specializes in enterprise‑level Quality Systems design, regulatory strategy, inspection readiness, and executive‑level advisory support. Her leadership style blends clarity, empathy, and operational excellence helping teams stabilize, scale, and succeed.

Focus Areas:

  • Quality Systems Architecture & Optimization 
  • Regulatory Strategy and Global Inspection Support
  • AI Risk Management & Emerging Technology Governance
  • Interim QA Leadership and Organizational Development
  • Continuous Improvement and Culture Transformation

Dawn Speidel, MS

Partner, GxP Quality Expert

Dawn brings 20+ years of global GMP leader with deep experience across vaccines, biologics, and advanced therapeutics. Dawn has built and led high‑performing Quality organizations, served as VP of Quality & Validation, and published in BioProcess International. She specializes in enterprise‑level Quality Systems design, regulatory strategy, inspection readiness, and executive‑level advisory support. Her leadership style blends clarity, empathy, and operational excellence helping teams stabilize, scale, and succeed.

Focus Areas:

  • Quality Systems Architecture & Optimization 
  • Regulatory Strategy and Global Inspection Support
  • AI Risk Management & Emerging Technology Governance
  • Interim QA Leadership and Organizational Development
  • Continuous Improvement and Culture Transformation

Liliana Sanchez 

Senior Consultant, Supplier Quality & CMO Oversight

Liliana brings 5+ years of hands‑on Supplier Quality and CMO oversight experience across complex manufacturing networks. She has led qualification audits, managed global vendor programs, and strengthened compliance for CDMOs, labs, and critical suppliers. Known for her sharp analytical skills and collaborative approach, she ensures external partners meet expectations while supporting clients with practical, phase‑appropriate solutions.

Focus Areas:

  • Supplier Quality & CMO/CDMO Oversight
  • Qualification Audits & Ongoing Vendor Monitoring
  • Quality/Technical Agreement Development
  • Risk Management
  • Documentation, Deviation, and CAPA Support

Liliana Sanchez 

Senior Consultant, Supplier Quality & CMO Oversight

Liliana brings 5+ years of hands‑on Supplier Quality and CMO oversight experience across complex manufacturing networks. She has led qualification audits, managed global vendor programs, and strengthened compliance for CDMOs, labs, and critical suppliers. Known for her sharp analytical skills and collaborative approach, she ensures external partners meet expectations while supporting clients with practical, phase‑appropriate solutions.

Focus Areas:

  • Supplier Quality & CMO/CDMO Oversight
  • Qualification Audits & Ongoing Vendor Monitoring
  • Quality/Technical Agreement Development
  • Risk Management
  • Documentation, Deviation, and CAPA Support