Melaleuca: The Wellness Company
Sr. Director of Global Quality & Regulatory Compliance
Melaleuca: The Wellness Company, Idaho Falls, Idaho, United States, 83401
Sr. Director of 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 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. Summary 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. Responsibilities 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. 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. 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. 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. 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. Proven ability to lead multi-site operations and deep knowledge of federal regulations regarding the manufacturing and distribution of drug products, nutritional supplements, and food safety. 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. Melaleuca is an equal opportunities employer and welcomes applications from diverse candidates.
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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 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. Summary 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. Responsibilities 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. 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. 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. 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. 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. Proven ability to lead multi-site operations and deep knowledge of federal regulations regarding the manufacturing and distribution of drug products, nutritional supplements, and food safety. 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. Melaleuca is an equal opportunities employer and welcomes applications from diverse candidates.
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