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Arrae · 1 day ago

Senior Manager of Quality Assurance

Los Angeles, CA

Full-time

Onsite

Senior Level

5+ years exp

Arrae is seeking a Senior Manager of Quality Assurance to build and scale their Quality Management System (QMS). This hands-on leadership role will involve designing SOPs, ensuring regulatory compliance, and overseeing quality processes across product development and supply chain operations.

Dietary SupplementsFitnessHealth CareWellness

Responsibilities

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

Qualification

Quality Assurance experienceSOPsQMS infrastructureFDA cGMPs expertiseManaging CMOsSuppliersTechnical writing skillsJudgmentAutonomyComfort operating in ambiguity