Kymbre D.

About Kymbre D.

With over six years of experience in quality assurance and regulatory affairs, I currently serve as a Quality and Regulatory Affairs Specialist at Henry Schein. My work through internal and external audits involves implementing quality strategies, coordinating policies, and directing FDA-compliant regulatory programs for global manufacturers and subsidiaries. My expertise includes deploying effective quality best practices, overseeing new business processes aligned with FDA regulations, and collaborating with leadership to ensure vendor compliance with regulatory programs. I bring a strong foundation in document review and analysis, which I leverage to optimize processes, improve accuracy, and drive compliance. My work has led to measurable improvements, including a 24% year-over-year improvement in redocumentation rates through optimized coding tools. With certifications in Root Cause Analysis and Supplier Auditing, I am dedicated to fostering collaboration and excellence in quality and regulatory processes.

Experience

1. Quality Assurance & Regulatory Affairs Specialist

   Henry Schein

   Mar 2021 — Present · Melville, NY, US

   Audit, Compliance & Quality Systems• Lead internal corporate audits of quality systems, SOPs, and regulatory workflows to ensure compliance with FDA, GxP, ISO 13485, and QSR requirements.• Conduct external supplier audits (desktop, virtual, and onsite) for pharmaceutical, medical device, and corporate brand manufacturers, assessing quality systems, regulatory documentation, and supplier risk.• Execute supplier qualification and requalification audits, including vendor onboarding, periodic reviews, and ongoing compliance monitoring.• Perform regulatory data and attribute audits validating FDA 510(k), PMA, NDC, GUDID, FDA registrations, device classifications, and product codes.• Identify audit findings, nonconformances, and gaps; collaborate cross-functionally to drive CAPA development, remediation, and closure.• Maintain audit documentation, reports, and evidence in alignment with inspection readiness and audit trail requirements.Compliance, Risk & Governance• Serve as DQSA / DSCSA Subject Matter Expert, auditing supplier licensing, distribution authorization, and compliance with CLIA, REMS, and state/federal requirements.• Partner with Quality, Regulatory, Purchasing, and Legal to assess third-party risk, approve suppliers, and mitigate compliance exposure.• Support inspection readiness initiatives by strengthening quality governance, documentation controls, and regulatory data integrity.• Monitor and interpret evolving FDA guidance and regulatory changes, updating audit criteria and compliance processes accordingly.Audit Impact & Metrics• Reengineered the regulatory audit framework, resulting in a 54% improvement in item attribute compliance across audited suppliers.• Reduced audit remediation timelines by 70% through standardized audit protocols, risk-based prioritization, and statistical analysis.• Improved audit resolution time by developing structured audit communication and escalation pathways.

Education

• Stony Brook University

  Bachelor of Science, Business Administration and Management, General

• Stony Brook University

  Bachelor's degree, Business Administration, Management and Operations