Zoé Rosa

Consultant | Director of Moderately Complex Labs

  • Credentials:
    Quality Management System; Project Management; GLP; GMP; ICH E6 (R2) Good Clinical Practice (GCP); ISO assessments; Clinical chemistry; Clinical hematology; Immunology; Microbiology; Molecular infectious disease; Pathology and Cytology
  • Experience:
    An accomplished Laboratory Director and Project Manager with extensive experience in managing complex laboratory projects and ensuring the highest standards of quality. Proven expertise in implementing and overseeing Quality Management Systems (QMS), with a strong focus on ISO, CLIA, and various regulatory frameworks. As an international assessor, has successfully evaluated and audited laboratories for compliance with global standards. Key areas of proficiency include clinical research, where a deep understanding of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) is applied to ensure accuracy and safety in all processes. Additionally, holds an MBA with a focus on strategic planning and leadership, driving operational efficiency, innovation, and growth within laboratory environments. Skilled at aligning teams to achieve regulatory compliance and quality excellence while fostering collaboration across departments to deliver on key project milestones.
  • States:
    Nationwide