Position SummaryThe 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 is a highly visible "build" role responsible for establishing and scaling quality processes, supplier qualification programs, audit systems, and complaint management procedures that ensure compliance with 21 CFR Part 111 and applicable dietary supplement regulations.
Reporting directly to executive leadership, this individual will serve as the quality subject matter expert and play a critical role in protecting product integrity, regulatory compliance, and consumer trust.
Key ResponsibilitiesQuality Systems & Compliance
- Maintain and continuously improve the Quality Management System (QMS), including SOPs, specifications, batch records, deviations, CAPA, and change control processes.
- Ensure compliance with 21 CFR Part 111 and applicable dietary supplement regulations.
- Partner with Product Development and Operations on specifications, stability programs, and product release testing.
- Drive a culture of continuous improvement and quality excellence.
Contract Manufacturer Audits
- Develop and execute a risk-based audit program across all manufacturing partners.
- Conduct on-site and remote GMP audits evaluating quality systems, documentation practices, sanitation programs, and manufacturing controls.
- Issue audit reports, track CAPAs, and verify timely closure of findings.
- Maintain audit readiness across all operational facilities.
Consumer Complaint Management
- Build and manage an end-to-end complaint handling system.
- Establish investigation workflows, escalation procedures, and adverse event reporting processes.
- Lead root cause investigations and CAPA implementation.
- Monitor complaint trends and provide actionable insights to Quality, Regulatory, and Product Development teams.
Supplier Qualification
- Develop and manage supplier qualification and approval programs.
- Review specifications, Certificates of Analysis, identity testing requirements, and supplier documentation.
- Conduct supplier risk assessments and maintain Approved Supplier Lists.
- Manage supplier performance monitoring, requalification activities, and change control processes.
QualificationsRequired
- 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.
Preferred
- Experience with oral pouch, buccal, or alternative delivery systems.
- ASQ certifications such as CQA, CQM, CQE, or equivalent.
- Experience supporting high-growth consumer products or dietary supplement organizations.
