Holly Randolph
Associate Director Quality Assurance @IQVIA
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WORK HISTORY
Associate Director Quality Assurance @IQVIA
EDUCATION
Penn State University
Bachelor's degree, Biology - Vertebrate Physiology
East Stroudsburg University of Pennsylvania
Master of Science - MS, Biology
East Stroudsburg University of Pennsylvania
Masters, Biology
Penn State University
Bachelor of Science - BS, Biology
SKILLS
ABOUT HOLLY RANDOLPH
Experienced Global Quality Assurance Professional, well versed in GCP (DCT, RWE, ePRO, surveys, observational, PASS) as well as GMP (manufacturing, packaging, warehousing and distribution) regulations for medical devices, vaccines, multi-presentation branded and generic pharmaceuticals (solid oral, ODT, capsules, lyophilized, sterile injectables, chemotherapeutics). Solid understanding of Decentralized, Hybrid and Traditional site-based Clinical Trials, including exposure to cutting edge technology (apps, wearables)Specialties: Auditing (internal, external, supplier, for cause, due diligence), all facets of Quality Assurance and Quality Systems, QMS implementation, Incident/CAPA/Change Control oversight, coordinating and hosting regulatory inspections, personnel management, vendor management, possess strong knowledge of process and system validation, ITQA, warehousing and distribution QA, supply chain, transportation logistics, GDPs, Serialization - Track and Trace, import/export, incoterms, FDA, Health Canada, ANVISA, EU, ICH, ISO 9001, 13485 and 27001.ASQ Certified Quality Auditor (CQA)- Lean Six Sigma Green Belt and Champion
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