Chief Quality Officer

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

• Lead the development, implementation, and maintenance of quality management systems in compliance with all FDA regulations and GMP standards.
• Oversee the entire quality control process, including raw material verification, in-process quality checks, and finished product testing.
• Oversee laboratory operations.
• Manage and enhance the supplier qualification program to ensure raw materials meet required quality and regulatory standards.
• Coordinate with R&D and production teams to implement quality standards and improve product consistency and safety.
• Lead internal audit programs to identify potential quality issues and implement corrective actions in a timely manner.
• Maintain up-to-date knowledge of industry trends, new regulatory requirements, and best practices in quality management.
• Train and mentor quality assurance staff and oversee their daily activities and performance.
• Manage the handling of customer relations related to product quality, investigating issues and developing solutions to prevent recurrence.
• Prepare and present detailed quality reports to senior management and relevant regulatory bodies.
• Collaborate with external auditors and regulatory officials during inspections and provide necessary documentation.
• Serve as Quality representative to all external organizations.
• Establish key metrics and Quality Strategy in line with Company objectives.

Required Qualifications:

• Minimum Bachelor’s Degree in a scientific field such as Food Science, Chemistry, Biochemistry, Engineering, or related field.
• Minimum of 15 years’ experience in quality control or quality assurance in the dietary supplement or pharmaceutical industry, with at least 5 years in a managerial capacity.
• Deep understanding of FDA regulations (CFR 21 part 111, 210, 211 and 11), GMP, HACCP, and ISO standards relevant to dietary supplements.
• Deep understanding or dietary supplement and pharmaceutical standards – experience in GRMA certification programs.
• Proven experience in handling audits and compliance with regulatory bodies.
• Strong leadership skills and experience managing a quality assurance team.
• Excellent organizational, communication, and interpersonal skills.
• Knowledge of modern IT solutions in the space of Quality Management System

Preferred qualifications:

• Master’s degree in a relevant scientific discipline.
• Certifications related to quality management (e.g., Certified Quality Auditor, Certified Quality Manager).
• Experience with lean manufacturing and continuous improvement processes.
• Experience in managing laboratory operations.
• Experience in managing External Manufacturers and vendors.
• Prove track record in digitalization and management of transformation.
• Experience in implementing QMS.
• Experience in automation and in-line process controls.
• Proven track record in establishing effective teams.
• Experience in creation and implementation of Quality strategy.

Skills:

• Exceptional analytical and problem-solving skills.
• Ability to multitask and manage multiple projects simultaneously under tight deadlines.
• Strong attention to detail and a commitment to delivering high-quality products.
• Proficient in using quality management software and tools.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.