Sr Quality Manager

Keystone & Golden, Inc.; Lexington (KY); On-site; USD 85,000 - 110,000; Full time

Job summary

Keystone & Golden, Inc. is seeking a Senior Quality Manager to lead quality systems across the supply chain in Lexington, KY. This role is critical for ensuring compliance with dietary supplement regulations and protecting product integrity.

The ideal candidate will have a Bachelor's degree in a scientific discipline and over 5 years of quality experience in food or consumer products. The position emphasizes building a quality infrastructure and continuous improvement.

Qualifications

• 5+ years of quality experience within dietary supplements, food, pharmaceuticals, or consumer products.
• Experience leading or supporting supplier qualification programs and GMP audit initiatives.
• Experience implementing or managing quality tracking and complaint management systems.

Responsibilities

• Maintain and continuously improve the Quality Management System (QMS).
• Develop and execute a risk-based audit program across all manufacturing partners.
• Build and manage an end-to-end complaint handling system.
• Develop and manage supplier qualification and approval programs.

Skills

Quality Management System (QMS)

GMP requirements

CAPA systems

Complaint handling processes

Supplier quality management

Investigative skills

Problem-solving skills

Root-cause analysis

Education

Bachelor's degree in Chemistry, Food Science, Microbiology, or related discipline

Tools

Quality tracking systems

Job description

About the Company

Our client is a rapidly growing consumer health and wellness company that has quickly become a category leader in functional oral pouch products. Backed by top-tier consumer investors, industry operators, and professional athletes, the company is redefining performance-focused products through science-backed innovation and premium quality standards.

This is a unique opportunity to join a high-growth organization during a pivotal stage of expansion and help build the quality infrastructure that will support future growth.

Position Summary

The 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 Responsibilities

Quality 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.

Qualifications

Required

• 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.