Senior Manager of Quality Assurance

The 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.

• Architect, write, implement, and continuously improve SOPs, work instructions, templates, and quality policies across the product lifecycle
• Build and scale the QMS, including document control, change management, deviations, CAPAs, training, and quality risk management
• Establish standardized, audit-ready quality processes for new product launches, reformulations, packaging changes, and supplier onboarding
• Ensure SOPs are practical, adopted by cross-functional teams, and aligned with business realities

• Ensure ongoing compliance with FDA cGMPs (21 CFR 111), DSHEA, and applicable international regulations
• Serve as a quality partner to Regulatory and Product teams on label reviews, claims substantiation, and regulatory submissions
• Lead preparation for and participation in internal audits, third-party audits, and regulatory inspections

• Own quality oversight strategy for CMOs, suppliers, and third-party laboratories
• Review and approve batch records, CoAs, and finished product release documentation
• Lead supplier qualification, audit programs, and performance monitoring
• Define and enforce testing requirements (identity, micro, heavy metals, potency, stability) via SOPs and quality agreements

• Build and oversee stability testing programs, data trending, and shelf-life justification
• Lead quality risk assessments for new dosage forms, formulation changes, packaging updates, and clinical studies
• Partner with Product Development to ensure quality considerations are embedded early in formulation and scale-up decisions

• Own deviation management, root cause analysis, and CAPA effectiveness
• Oversee complaint investigations and ensure timely, compliant resolution
• Track and report quality KPIs and present trends and risks to leadership

• Serve as a senior quality leader and subject matter expert across the organization
• Train and mentor cross-functional partners on SOPs, GMPs, and quality expectations
• Influence without authority, ensuring quality is embedded into how the business operates—not bolted on

• 5–8+ years of Quality Assurance experience in dietary supplements, nutraceuticals, food, or consumer health
• Proven experience building SOPs and QMS infrastructure
• Deep expertise in FDA cGMPs (21 CFR 111) and supplement regulatory requirements
• Experience managing CMOs, suppliers, and third-party labs
• Exceptional technical writing, documentation, and organizational skills
• Strong judgment, autonomy, and comfort operating in ambiguity

• Experience supporting clinical studies or scientific publications
• International regulatory experience (Canada, EU, etc.)
• Audit leadership experience (internal and external)
• Background in formulation, product development, or regulatory affairs

This role will define how quality scales ’ll build systems that protect consumers, enable innovation, and support long-term growth—while moving fast and staying audit-ready.

Interested 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.