Senior Manager of Quality Assurance

Quality System Architecture & SOP Ownership

• 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

GMP Compliance & Regulatory Partnership

• 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

Supplier, CMO & Testing Oversight

• 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

Product Quality, Stability & Risk Management

• 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

Deviations, Complaints & CAPA Leadership

• 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

Leadership & Enablement

• 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

Nice to Have

• 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