Senior Manager, Quality Assurance & Regulatory

Remote, USA Full-time
Job Description:• Develop, implement, and maintain QA policies and procedures in compliance with FDA regulations. • Conduct GMP audits of co-manufacturers to maintain high standards of product quality and safety. • Lead investigations into product complaints, implementing corrective and preventive actions as needed. • Review Certificates of Analysis (CoAs) and 3rd party testing for all finished goods. • Ensure compliance with Prop 65 and other contaminant testing requirements (heavy metals, microbials)• Review Supplement Facts Panels, ensuring accurate DV%, ingredient units, and botanical specifications.• Vet all structure-function claims for regulatory compliance and scientific substantiation. • Oversee international regulatory requirements including COFEPRIS, EFSA, and Health Canada. Requirements:• Bachelor’s or Master’s degree in Food Science, Chemistry, Biology, or related discipline. • 5–10 years’ QA/RA experience within dietary supplements, CPG, or food/beverage industry. • Deep understanding of FDA regulatory requirements, including cGMP and labeling regulations. • Experience managing audits, recalls, and compliance inspections.• Proficiency in ingredient and product testing protocols and interpreting CoAs. • Excellent analytical, problem-solving, and communication skills. Benefits:• Implement and oversee stability testing and shelf-life studies to ensure accurate expiration dating. • Manage product recall readiness, including conducting periodic mock recalls. Apply tot his job
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