Amy Wotawa's Linkedin Analytics

I've spent the majority of my career in quality, auditing, and QA consulting. With 15 years of direct industry experience, my depth of experience in QA, vendor management, and client service delivery enables a uniquely global perspective in bringing quality best practices to the pharmaceutical industry as Associate Head of Practice (GCP US, GMP, CSV, GLP) at Zigzag Associates, Ltd., a global QA services consulting firm. As a Lead Auditor and subject matter expert in GLP and GCLP QA/regulatory compliance, I help pharma and biotech organizations reach their vendor management program goals beyond just checking the compliance box. Vendor relationships matter, so choosing the right audit partner is essential. My technical focus is primarily on GLP/GCP laboratory and biorepository service providers: -Audits: vendor qualifications/surveillance/directed -Gap assessments -Quality Assurance/GxP consulting -Quality Management System (QMS) design/support/remediation -Corrective and preventive action (CAPA) support Some examples of my therapeutic areas and discipline expertise include: -Oncology -Cell & Gene Therapy -Cytogenetics/FISH -Immunology -Immunohistochemistry -Pathology -Histopathology -Flow Cytometry -Molecular Genetics/NGS -Safety assessment/Toxicology -Biomarkers CONNECT with me here on LinkedIn