Stacy Newalu
Vice President, Quality Services @Advanced Clinical
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WORK HISTORY
Vice President, Quality Services @Advanced Clinical
Provide strategic leadership and direction for Advanced Clinical\'s Quality Services function - a direct contracting service that conducts Quality Assurance, GxP compliance, and inspection readiness activities (i.e, GxP audits, gap assessments, inspection readiness activities and support, Standard Operating Procedure (SOP) development/ revision, specialized consulting, etc.) on behalf of pharmaceutical and biotechnology companies. Lead Advanced Clinical Regulatory Inspections; coordinate and manage inspection preparation and conduct for inspections of Advanced Clinical and support Client Regulatory Inspections involving Advanced Clinical’s services. Support a team of Senior Quality Auditors and Project Managers.
EDUCATION
University of South Florida
MPH, Public Health/Infectious Disease
University of Massachusetts Amherst
BS, Microbiology
University of Massachusetts Amherst
BS, Medical Technology
SKILLS
ABOUT STACY NEWALU
Clinical research compliance and regulatory expert with 25+ years of experience driving quality, integrity, and compliance within clinical research regulated programs. Recognized QA leader skilled in assessing regulatory compliance in global settings (FDA, ICH, EMA, MHRA, and other international regulatory frameworks), partnering cross‑functionally to drive operational excellence, preparing for and hosting regulatory inspections, and leading and developing high‑performing QA teams. Committed to building robust quality systems, strengthening inspection readiness, and enabling organizations to deliver safe, compliant, and high‑quality clinical data.
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