Sr. Director of Global Quality & Regulatory Compliance

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.

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.

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.

• 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.

• 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.

• Supervises related staff by performing such duties as recommending employment status (i.e., hiring, terminating, promotions, issuing…