Arrae
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.
Key Responsibilities 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
Qualifications
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
Why This Role Matters This 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 Apply 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
careers@arrae.com
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.
#J-18808-Ljbffr
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 Responsibilities 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
Qualifications
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
Why This Role Matters This 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 Apply 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
careers@arrae.com
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.
#J-18808-Ljbffr