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Melaleuca: The Wellness Company · 3 weeks ago

Sr. Director of Global Quality & Regulatory Compliance

Idaho Falls, ID

Full-time

Onsite

Director/Executive

15+ years exp

Melaleuca is a purpose-driven company that enhances lives by helping people reach their goals. The Senior Director of Global Quality Assurance & Regulatory Compliance will lead internal manufacturing quality systems and regulatory compliance programs across all global operations, ensuring adherence to Good Manufacturing Practices and regulatory standards.

Cosmetics

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 (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 warnings, etc.) interviewing applicants, counseling, training, scheduling, resolving conflicts, coordinating with other departments, conducting associate meetings, recommending wage increases, etc

Qualification

Quality AssuranceRegulatory ComplianceQuality Management SystemLeadershipGMP StandardsCAPATechnical WritingTeam DevelopmentCross-Functional CollaborationPresentation Skills

Required

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