Director of Quality
2 days ago
Spanish Fork
Director of Quality Food & Dietary Supplement Contract Manufacturing We are seeking an experienced and strategic Director of Quality to lead and oversee all quality assurance, food safety, regulatory compliance, and certification programs for a fast-paced Food and Dietary Supplement Contract Manufacturing organization. This leadership role is responsible for developing and maintaining robust quality systems that ensure compliance with FDA regulations, customer requirements, and third-party certification standards while driving continuous improvement across the organization. Key Responsibilities • Lead the development, implementation, and continuous improvement of Quality Management Systems (QMS), Food Safety Plans, SOPs, and compliance programs., • Ensure compliance with 21 CFR Parts 111, 117, 101, 110, 210, and 211, FSMA, DSHEA, FDA, FTC, and applicable regulations., • Oversee CAPA, deviation management, investigations, complaint handling, and document control systems., • Direct regulatory affairs activities including labeling compliance, structure/function claims substantiation, NDI/ODI/GRAS evaluations, and product registrations., • Review and approve formulations, specifications, master manufacturing records, and product labels., • Lead Food Safety and Preventive Controls programs including HACCP, SQF, sanitation, allergen control, and supplier qualification programs., • Manage facility and product certifications including SQF, NSF, Organic, Gluten-Free, NGPV, Kosher, Halal, etc., • Host customer audits, FDA inspections, and third-party certification audits., • Provide leadership and development for Quality, Regulatory, Sanitation, and Document Control teams., • Collaborate cross-functionally with R&D, Operations, Supply Chain, Sales, and Customer Success teams., • Oversee communications with third party laboratory operations, microbiological testing, environmental monitoring, and validation programs., • Drive continuous improvement initiatives and monitor KPIs to enhance quality performance. Qualifications • Bachelor’s degree in Microbiology, Food Science, Chemistry, Biology, or related scientific field, Or equivalent experience in a related field, • 10+ years of Quality and Regulatory experience in dietary supplements, food, nutraceuticals, pharmaceuticals, or related manufacturing industries., • Minimum 5 years of leadership experience managing Quality and/or Regulatory teams., • Strong working knowledge of FDA dietary supplement and food regulations, cGMP requirements, FSMA, labeling compliance, and certification programs., • Experience supporting FDA inspections and customer audits in a contract manufacturing environment., • Excellent leadership, communication, organizational, and problem-solving skills. Preferred Certifications • PCQI (Preventive Controls Qualified Individual), • HACCP Certification, • SQF Practitioner Certification, • ASQ Certifications (CQE, CQA, CQM, etc.) What We Offer • Competitive salary and benefits package, • Opportunity to lead quality and regulatory strategy for a growing organization, • Collaborative and innovation-driven work environment, • Career growth and leadership development opportunities If you are passionate about food safety, regulatory excellence, and building world-class quality systems in the dietary supplement and food manufacturing industry, we encourage you to apply.