Sr. Director of Global Quality & Regulatory Compliance

Company Profile

Senior Director, Global Quality & Regulatory Compliance

Melaleuca is a purpose-driven company that enhances lives by helping people reach their goals. For nearly 40 years, we have been a legacy of stability in the wellness industry, operating with no layoffs in our history. This commitment to our team has earned us recognition from Forbes as one of "America's Best Midsize Employers" and from USA Today as one of the "Best Companies to Work For." Our focus on superior products and our unwavering mission has fueled our growth and created a uniquely family-oriented and stable work environment. We're looking for a leader who is ready to make a genuine impact.

Overview

This is a premier opportunity for a proven leader to join a company dedicated to excellence in manufacturing and premium product quality.The Senior Director of Global Quality Assurance & Regulatory Compliance will lead our internal manufacturing quality systems and regulatory compliance programs across all global operations. This role is responsible for ensuring consistent, world-class execution of Good Manufacturing Practices (GMP) and regulatory adherence across all owned manufacturing facilities producing dietary supplements, personal care items, foods, and over-the-counter (OTC) drug products. Responsible for designing and managing a robust Quality Management System (QMS) for the production of current and future products.  FDA responsibilities include compliance to Drug Laws (21 CFR 210,211), Supplement Laws (21 CFR 111) and Food Laws (FSMA, HACCP). This individual will be a key quality leader within the organization, leading and partnering cross-functionally to ensure our products meet all internal standards and external regulatory requirements.

Responsibilities

Manufacturing Quality Leadership

• Direct the development and implementation of all Quality Assurance programs, ensuring the appropriate preventive measures and controls are in place within our manufacturing systems.
• Lead the development, implementation, and governance of a global Quality Management System (QMS) aligned with 21 CFR Parts 111, 210/211, and international GMP standards (e.g., EU GMP, Health Canada).
• Oversee manufacturing site compliance to QMS standards across multiple locations, including batch record review, change control, deviation handling, investigations, CAPA management, and product release.
• Define and enforce corporate quality policies, SOPs, and standards across all internal manufacturing operations.
• Drive continuous improvement initiatives in manufacturing QA, ensuring effective root cause investigations and preventive actions.
• Provide QA oversight for technology transfers, scale-up activities, and new facility commissioning and qualification.

Regulatory Compliance & Inspection Readiness

• Serve as the lead regulatory compliance officer for internal operations; oversee inspection readiness and host audits from FDA, NSF, Health Canada, and other global regulatory bodies.
• Coach, mentor and teach manufacturing facilities and QA staff the necessary elements of preventive quality systems, ensuring a principle based approach is applied throughout the facilities.
• Maintain a strong state of control across all GMP sites by conducting regular internal audits and compliance reviews.
• Develop global strategies for responding audit findings, inspection reports, or other regulatory actions, and lead remediation programs as needed.
• Monitor and interpret emerging regulatory trends; translate changes into actionable policies and training for manufacturing teams.

Cross-Functional Leadership

• Collaborate closely with Manufacturing, Quality Control, Regulatory Affairs, R&D, and Operations to align quality expectations across all phases of product lifecycle.
• Lead the Quality Assurance function across multiple manufacturing locations, building high-performing teams and driving accountability through clear KPIs and quality objectives.
• Report on quality system metrics, risk areas, and improvement plans to senior leadership on a regular basis.

Supervision of Others

• Supervises related staff by performing such duties as recommending employment status (i.e., hiring, terminating, promotions, issuing warnings, etc.) interviewing applicants, counseling, training, scheduling, resolving conflicts, coordinating with other departments, conducting associate meetings, recommending wage increases, etc. 

Qualifications

• Ability to relocate to Idaho Falls, ID and work in office 5 days a week (Relocation Assistance Provided)

• Bachelor's degree with 15+ years of progressive experience in Quality Assurance or Quality Systems Management within a regulated industry (food, drugs, or nutritional supplements) with 5+ years of experience in a senior leadership role within QA must have a proven background in leading and developing other leaders

• Proven ability to lead multi-site operations - 

• Deep knowledge of federal regulations regarding the manufacturing and distribution of drug products, nutritional supplements, and food safety (21 CFR 210, 211, 111).

• Strong working knowledge of quality system tools like CAPA, change control and QMS platforms.

• Exceptional leadership skills with a track record of developing large, diverse teams.

• Excellent technical writing, verbal, and presentation skills.

Why Melaleuca

• A Culture of Mission and Impact: Our mission is to enhance lives by helping people reach their goals. This purpose-driven culture is felt in every aspect of our work, creating a rewarding environment where you can see the direct impact of your contributions.

• A Legacy of Stability: For nearly 40 years, Melaleuca has operated with a remarkable record of no layoffs. We are a financially strong, private company committed to our employees' security and long-term success.

• Award-Winning Workplace: Our commitment to our team has been recognized nationally. We are proud to be named by Forbes as one of "America's Best Midsize Employers" and by USA Today as one of the "Best Companies to Work For."

• Commitment to Quality: We are relentless in our pursuit of premium products. As a science-driven company, we invest heavily in research, development, and quality assurance to ensure our customers receive the very best.

• Professional Growth: We are committed to developing our people. Melaleuca provides opportunities for continuous learning and career advancement, allowing you to grow your skills and build a long-term career with us.