Senior Manager, Quality Assurance & Regulatory
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.
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