President & Founder · Certified Quality Auditor (CQA)
A senior Regulatory, Quality, and Supply Chain leader with more than 25 years of experience driving global quality system compliance, supplier oversight, and operational excellence across pharmaceutical, medical device, biotechnology, and combination product environments.
Certified Quality Auditor with risk-based auditing expertise
FDA, ISO, EU MDR & international regulatory requirements
Supplier qualification, CAPA & commercialization readiness
Medical Device & Pharmaceutical Consulting
Wayner Williams is a senior Regulatory, Quality, and Supply Chain leader with more than 25 years of experience driving global quality system compliance, supplier oversight, and operational excellence across pharmaceutical, medical device, biotechnology, and combination product environments. A Certified Quality Auditor (CQA), she has extensive expertise in GxP vendor management, supplier qualification, risk-based auditing, CAPA management, and commercialization readiness aligned with FDA, ISO, EU MDR, and international regulatory requirements.
Wayner is the founder of Medical Device & Pharmaceutical Consulting, which supports product launches, supplier evaluation, Quality Management System remediation, and global compliance initiatives. She has worked extensively with contract manufacturers, API suppliers, logistics centers, sterilization providers, and contract laboratories to strengthen supplier capability, compliance, and supply continuity.
She has also led the development, remediation, and implementation of Quality Management System processes, procedures, and training programs designed to ensure sustainable compliance with FDA, ISO, and global regulatory requirements. Her experience includes conducting gap assessments, strengthening CAPA and audit readiness programs, and building scalable quality system frameworks that support commercialization and operational growth.
Led global CGMP audits across APIs, sterile and non-sterile drug products, medical devices, combination products, and contract service providers.
Drove design control remediation, CAPA effectiveness, regulatory harmonization, and product lifecycle management initiatives that supported significant business and pipeline growth.
Supports product launches, supplier evaluation, QMS remediation, and global compliance initiatives across the medical device and pharmaceutical industries.
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