Quality Manager

POSITION DESCRIPTION

Quality Manager

LOCATION:

Louisville, CO 80027

REPORTS TO:

Director of Quality

FLSA STATUS:
Exempt

JOB TYPE:
Full-time

DIRECT REPORTS:
Quality Assurance Team and Sanitation Employees

The Quality Manager is responsible for managing and executing quality assurance and quality control operations within Arc Well Manufacturing's dietary supplement business. This role ensures that products comply with regulatory standards, industry guidelines and internal quality requirements to deliver safe, effective and high-quality dietary supplements.

The Quality Manager implements and maintains quality systems, policies and procedures while promoting a culture of continuous improvement, compliance and cross-departmental collaboration. This individual serves as a key auditor and primary contact for regulatory audits, and works closely with production, purchasing and executive leadership to keep quality standards embedded in every stage of the business.

Success in this role requires strong leadership, deep regulatory knowledge and the ability to make sound decisions under pressure. The Quality Manager must be comfortable managing people, programs and priorities simultaneously in a fast-paced, highly regulated manufacturing environment.

• Provide direction and oversight to the quality assurance team, ensuring alignment with company goals.
• Oversee the integration of product specifications by collaborating with relevant departments.
• Support manufacturing processes by reviewing product formulations for claim substantiation and verifying necessary overages with the formulation team.
• Develop and communicate product specifications to all relevant departments, including outsourced manufacturers and partners.
• Oversee vendor verification for materials, components and outsourced processes, maintaining effective communication with the purchasing team.
• Conduct label reviews, regulatory evaluations and claim substantiations to ensure compliance, accuracy and error-free marketing materials.
• Oversee formulation processes and improvements for product innovation and technology transfers.
• Maintain documentation for registrations, certifications, renewals, inquiries and audits.
• Stay current on regulatory and compliance requirements, implementing continuous improvement across all departments.
• Ensure compliance with all FDA and company product safety and quality policies.
• Adhere to and enforce the Product Safety & Quality programs.
• Build skills and capabilities in quality and production staff through training and development.
• Manage consumer complaints and response times, change control processes, investigations and on-time CAPA closure.
• Conduct facility inspections and proactively address quality issues with interdepartmental impact.
• Oversee internal and external quality audits, including repeat findings, serving as a key auditor and primary contact for regulatory audits.
• Manage HACCP/Food Safety Plans, employee training programs, product recalls, allergen control and cross-contamination programs.
• Review and approve Standard Operating Procedures (SOPs), oversee document control and serve on the Material Review Board.
• Oversee vendor qualification, pest control, label control and verification, testing and batch release programs, retain programs, receiving programs, stability programs, expiration dating, raw material qualification and equipment programs.
• Manage sanitation employees and third-party cleaners for general facility cleaning.
• Work with the executive team to implement strategic goals for business development.
• Help manage inventory tracking, vendor relationships and develop facility standard work procedures and SOPs.

This is a senior leadership role that requires deep regulatory knowledge, sound judgment and the ability to hold cross-functional teams accountable to quality standards. The Quality Manager will work closely with production, purchasing and executive leadership at Arc Well Manufacturing to keep the facility in full compliance with FDA and GMP requirements.

The ideal candidate leads by positive example, communicates clearly across departments and takes ownership of the facility's quality systems from documentation through audits and investigations. This individual must be comfortable managing people, vendors and regulatory relationships simultaneously.

Success in this position requires someone who closes CAPAs on time, reduces repeat and total audit findings…