Roshunda Applewhite

About Roshunda Applewhite

Experienced quality professional with 20+ years of success in highly regulated industries including pharmaceuticals, medical devices, biologics, and food manufacturing. My expertise lies in leading corporate quality and supplier compliance programs that strengthen global quality systems, reduce risk, and support business continuity across complex supply chains.I’ve built and scaled global supplier audit programs, led cross-functional initiatives to align with evolving regulatory requirements, and driven quality systems improvements that are both compliant and sustainable. Known for a collaborative, solutions-focused approach, I work across functions and geographies to turn compliance challenges into operational strengths.Skilled in managing high-stakes audits, developing robust supplier qualification strategies, and fostering quality partnerships both internally and externally, I bring a strategic mindset grounded in hands-on expertise.Core Strengths & Specialties:• Global Supplier Qualification & Oversight• Corporate Audit Program Leadership (Internal & External)• 21 CFR Parts 210, 211, 820, 58 | ISO 13485 | ISO 9001• Risk-Based Quality System Development• CAPA Leadership & Compliance Strategy• Inspection Readiness (FDA, EMA, Notified Bodies)• Quality Systems Harmonization Across Sites & Divisions• Lean Six Sigma | Quality Metrics & Performance Monitoring• Technical Writing | Executive Communication | Cross-Functional Collaboration

Experience

1. Global Quality Compliance, Sr Manager

   Amgen

   Dec 2023 — Present

Education

• Tougaloo College

  BS, Chemistry

• Quantic School of Business and Technology

  Executive MBA - In Progress

• The Johns Hopkins University

  Biotechnology