Sr Quality Manager
On-site · Lexington, Kentucky, United States
Job Summary
Senior Quality Manager will lead quality systems across the entire supply chain, from raw material suppliers and contract manufacturers to distribution and consumer complaint management. This build-role establishes and scales quality processes, supplier qualification programs, audit systems, and complaint management procedures to ensure compliance with 21 CFR Part 111 and applicable dietary supplement regulations, protecting product integrity, regulatory compliance, and consumer trust. Responsibilities include maintaining and improving the Quality Management System (QMS) with SOPs, specifications, batch records, deviations, CAPA, and change control; conducting on-site and remote GMP audits; leading supplier qualification and performance monitoring; building end-to-end complaint handling workflows; and driving continuous improvement, CAPA implementation, and cross-functional collaboration with Product Development, Operations, Quality, Regulatory, and Learning from consumer products and oral pouch delivery systems. Preferred experience with oral pouch or buccal delivery and ASQ certifications.
Required Qualifications
- Bachelor's degree in Chemistry, Food Science, Microbiology, or related scientific discipline
- 5+ years of quality experience within dietary supplements, food, pharmaceuticals, or consumer products
- Experience leading or supporting supplier qualification programs and GMP audit initiatives
- Strong working knowledge of 21 CFR Part 111
- GMP requirements
- CAPA systems
- Complaint handling processes
- Supplier quality management
- Experience implementing or managing quality tracking and complaint management systems
- Strong investigative, problem-solving, and root-cause analysis skills
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