Head of Quality & Compliance — FDA/GMP Leader

Inw Group; Ogden (UT); On-site; USD 120,000 - 190,000; Full time

Job summary

Inw Group in Ogden, Utah seeks a senior Quality leader to develop, implement, and maintain FDA-regulated QMS for dietary supplements and pharmaceutical products. You will oversee QA/QC, supplier qualification, internal audits, and regulatory readiness, partnering with R&D and manufacturing to ensure product safety and compliance.

This role requires a Bachelor's in a scientific field and 15+ years in QA/QC, including 5+ years in management; strong knowledge of CFR 21 parts 111, 210, 211, GMP,

Qualifications

• Bachelor’s degree in a scientific field (e.g., Food Science, Chemistry, Biochemistry, Engineering)
• Minimum 15 years of QA/QC experience in dietary supplement or pharmaceutical industries, with 5+ years in management
• Deep knowledge of FDA CFR 21 parts 111, 210, 211, GMP, HACCP, and ISO standards for dietary supplements
• Experience with GRMA certification programs
• Proven audit leadership and regulatory compliance track record
• Strong leadership, organizational, and communication skills
• Knowledge of Quality Management System IT solutions

Responsibilities

• Lead development, implementation, and maintenance of QMS in compliance with FDA and GMP
• Oversee QA/QC processes from raw materials to finished products
• Manage laboratory operations and supplier qualification program
• Coordinate with R&D and production to improve product consistency and safety
• Lead internal audits and implement corrective actions
• Prepare quality reports for senior management and regulators
• Collaborate with external auditors and regulatory officials
• Serve as Quality representative to external organizations
• Establish Quality Strategy and key metrics aligned with company objectives

Skills

Leadership

Regulatory compliance

Analytical skills

Communication

Project management

Problem solving

Quality mindset

Education

Bachelor’s degree in a scientific field

Master’s degree preferred

Tools

Quality management software

Job description

Inw Group in Ogden, Utah seeks a senior Quality leader to develop, implement, and maintain FDA-regulated QMS for dietary supplements and pharmaceutical products. You will oversee QA/QC, supplier qualification, internal audits, and regulatory readiness, partnering with R&D and manufacturing to ensure product safety and compliance.

This role requires a Bachelor's in a scientific field and 15+ years in QA/QC, including 5+ years in management; strong knowledge of CFR 21 parts 111, 210, 211, GMP,