Director of Quality Assurance & Regulatory Compliance - Nutraceuticals
30 days ago
Hauppauge
Job Description Position Summary A growing dietary supplement manufacturer and packaging company is seeking an experienced, hands-on quality leader to direct its Quality Unit. The Director of Quality Assurance & Regulatory Compliance will have primary responsibility for the company's cGMP quality management system, NSF certification, regulatory inspection readiness, and product-quality decisions. This individual will serve as the company's principal representative during NSF, FDA, customer, and third-party audits and will have independent authority to place materials and products on hold, approve or reject materials and finished batches, require corrective action, and escalate quality or regulatory risks directly to senior management. Primary Responsibilities • Own and continuously improve the site Quality Management System in accordance with 21 CFR Part 111, applicable provisions of 21 CFR Part 117, NSF/ANSI 455-2, company procedures, and other applicable requirements., • Serve as the primary host and company representative for NSF, FDA, customer, and third-party audits and inspections., • Maintain continuous inspection readiness and manage audit preparation, responses, corrective actions, and timely closure of findings., • Establish, maintain, and approve quality procedures, specifications, controls, and records covering manufacturing, packaging, labeling, laboratory, and warehouse operations., • Review and approve master manufacturing records, batch production records, and relevant changes before implementation., • Exercise final Quality Unit authority over quarantine, release, rejection, reprocessing, and disposition of raw materials, packaging components, labels, in-process materials, and finished products., • Lead investigations involving deviations, nonconformances, out-of-specification results, foreign objects, contamination risks, and other unanticipated occurrences., • Own root-cause analysis, CAPA, change control, and effectiveness-verification programs., • Oversee supplier qualification and requalification, COAs, raw-material specifications, incoming-material controls, and applicable vendor quality agreements., • Oversee internal QC laboratory activities and external laboratory relationships, including sampling plans, scientifically valid methods, testing, data review, calibration, validation, stability, and reserve-sample programs., • Ensure documentation and data meet cGMP requirements for accuracy, completeness, traceability, and contemporaneous recording., • Direct complaint, return, adverse-event quality investigation, recall, and mock-recall processes in coordination with senior management and counsel., • Review product labels, Supplement Facts panels, ingredient declarations, and relevant product claims for regulatory compliance in collaboration with Product Development, Marketing, and legal counsel., • Support retailer and marketplace compliance requirements, including GMP certificates, COAs, laboratory documentation, and manufacturer relationship documentation., • Maintain applicable facility registrations, certifications, regulatory correspondence, and audit calendars., • Establish and monitor quality metrics, recurring management reviews, internal audit programs, and compliance-risk reporting., • Develop and deliver cGMP training for manufacturing, packaging, warehouse, laboratory, and administrative personnel., • Lead, coach, and develop Quality Assurance and Quality Control employees while promoting accountability, respectful communication, and constructive cross-functional problem solving., • Build documented succession and cross-training within the Quality Unit to eliminate single-person dependency for critical compliance functions. Authority The Director of Quality Assurance & Regulatory Compliance will have: • Independent authority to quarantine, hold, approve, reject, release, or require further investigation of materials and products., • Authority to stop or restrict an operation when product quality, consumer safety, or regulatory compliance may be compromised., • Direct and unrestricted access to senior executive leadership for material quality or compliance concerns., • Quality responsibilities organizationally distinct from Production and Manufacturing. Required Qualifications • Bachelor's degree in chemistry, biochemistry, pharmaceutical science, microbiology, food science, chemical engineering, or a related discipline, or an equivalent combination of education and directly relevant experience., • At least 8 years of progressive quality experience in dietary supplement, nutraceutical, food, or pharmaceutical manufacturing, with substantial direct dietary supplement experience strongly preferred., • At least 3 years leading a Quality Assurance, Quality Control, or regulatory compliance function., • Expert working knowledge of 21 CFR Part 111 and practical experience applying its requirements within a manufacturing facility., • Direct experience preparing for and personally leading NSF/ANSI 455-2, FDA, or comparable dietary supplement manufacturing audits and inspections., • Demonstrated experience with QMS administration, SOPs, document control, CAPA, deviations, OOS investigations, change control, supplier qualification, batch review, and product disposition., • Experience with tablet and capsule manufacturing and dietary supplement packaging operations., • Experience overseeing internal and third-party laboratory testing, COA review, and scientifically valid analytical or microbiological methods., • Strong written communication, documentation, judgment, and audit-room leadership skills., • Demonstrated ability to communicate respectfully and constructively with employees at every level of an organization. Preferred Qualifications • Master's degree in a relevant scientific discipline., • ASQ Certified Quality Auditor, Certified Manager of Quality/Organizational Excellence, or comparable credential., • NSF/ANSI 455-2 auditor training., • HACCP, PCQI, FSVP, food-defense, or recall-coordinator training., • Experience with USDA Organic, Amazon dietary supplement verification, or other retailer compliance programs., • Experience using ERP, electronic QMS, document-control, or LIMS systems. A Ph.D. is welcome but not required. Demonstrated dietary supplement cGMP leadership and successful audit experience are more important than academic credentials.
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