Extensive experience leading and supporting regulatory inspections and audits, including FDA pre-approval and routine surveillance inspections, state board of pharmacy inspections, customer audits, and third-party quality assessments; proven capability in inspection readiness, response strategy, remediation planning, and sustained compliance. Expert knowledge of FDA cGMP requirements, including 21 CFR Parts 210 and 211, as applied to sterile and non-sterile drug manufacturing in a 503B outsourcing facility, with practical experience implementing, maintaining, and remediating quality systems in alignment with FDA guidance and current enforcement trends.