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Stacy Newalu

Stacy Newalu

Clinical research quality and regulatory compliance leader

Tampa, Florida, United States
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Joined February 2026
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Summary

Regulatory and compliance subject matter expert with two decades of experience guiding GCP/GxP inspection readiness and quality assurance activities. advancedclinical+1
Former FDA Regulatory Health Project Manager and Safety RHPM who has served as a regulatory contact on FDA approval correspondence. advancedclinical+1
Advanced Clinical leader: manages the Quality Services team, leads global regulatory inspections, and provides QA, GxP compliance, and inspection readiness services to sponsors. advancedclinical+1
Scientifically trained public health professional with an MPH and dual BS degrees in microbiology and medical technology, and credentialed as RQAP-GCP and CCRC. advancedclinical+1
Engages in industry education and speaking (conference sessions on pharma–CRO partnerships and quality culture). sqa+1

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