Senior Manager of Quality Assurance

About the RoleThe Senior Manager of Quality Assurance will build, own, and scale Arrae’s Quality Management System (QMS). This is a highly impactful, hands-on leadership role for someone who has designed SOPs and quality frameworks from the ground up and can translate regulatory requirements into clear, scalable processes.This role sits at the intersection of Quality, Product Development, Operations, and Supply Chain and will be critical in supporting new product launches, clinical studies, retail expansion, and international growth.Key ResponsibilitiesQuality System Architecture & SOP OwnershipArchitect, write, implement, and continuously improve SOPs, work instructions, templates, and quality policies across the product lifecycleBuild and scale the QMS, including document control, change management, deviations, CAPAs, training, and quality risk managementEstablish standardized, audit-ready quality processes for new product launches, reformulations, packaging changes, and supplier onboardingEnsure SOPs are practical, adopted by cross-functional teams, and aligned with business realitiesGMP Compliance & Regulatory PartnershipEnsure ongoing compliance with FDA cGMPs (21 CFR 111), DSHEA, and applicable international regulationsServe as a quality partner to Regulatory and Product teams on label reviews, claims substantiation, and regulatory submissionsLead preparation for and participation in internal audits, third-party audits, and regulatory inspectionsSupplier, CMO & Testing OversightOwn quality oversight strategy for CMOs, suppliers, and third-party laboratoriesReview and approve batch records, CoAs, and finished product release documentationLead supplier qualification, audit programs, and performance monitoringDefine and enforce testing requirements (identity, micro, heavy metals, potency, stability) via SOPs and quality agreementsProduct Quality, Stability & Risk ManagementBuild and oversee stability testing programs, data trending, and shelf-life justificationLead quality risk assessments for new dosage forms, formulation changes, packaging updates, and clinical studiesPartner with Product Development to ensure quality considerations are embedded early in formulation and scale-up decisionsDeviations, Complaints & CAPA LeadershipOwn deviation management, root cause analysis, and CAPA effectivenessOversee complaint investigations and ensure timely, compliant resolutionTrack and report quality KPIs and present trends and risks to leadershipLeadership & EnablementServe as a senior quality leader and subject matter expert across the organizationTrain and mentor cross-functional partners on SOPs, GMPs, and quality expectationsInfluence without authority, ensuring quality is embedded into how the business operates—not bolted onQualifications5–8+ years of Quality Assurance experience in dietary supplements, nutraceuticals, food, or consumer healthProven experience building SOPs and QMS infrastructureDeep expertise in FDA cGMPs (21 CFR 111) and supplement regulatory requirementsExperience managing CMOs, suppliers, and third-party labsExceptional technical writing, documentation, and organizational skillsStrong judgment, autonomy, and comfort operating in ambiguityNice to HaveExperience supporting clinical studies or scientific publicationsInternational regulatory experience (Canada, EU, etc.)Audit leadership experience (internal and external)Background in formulation, product development, or regulatory affairsWhy This Role MattersThis role will define how quality scales at Arrae. You’ll build systems that protect consumers, enable innovation, and support long-term growth—while moving fast and staying audit-ready.How to ApplyInterested candidates should submit their resume and a brief cover letter outlining their relevant experience and why they would be a valuable addition to our team. Please send your application to with “Senior Manager of Quality Assurance” in the subject line.ARRAE, Inc. is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.