Quality Assurance & Regulatory Manager
$100,000–$100,000 year
On-siteIrvine, California, United States
Job Summary
Lead Quality Assurance and Regulatory functions across U.S. and China offices by managing the Quality Management System, supplier qualification programs, and regulatory compliance initiatives. Establish departmental KPIs, drive continuous improvement using data and risk-based decision making, and standardize quality processes across operations. Oversee customer technical support, complaint investigations, and audit preparations while ensuring all documentation remains accurate and compliant. Recruit, coach, and develop team members to foster accountability and cross-functional collaboration with Quality Control, Procurement, Sales, and Executive Leadership. Translate strategic initiatives into day-to-day execution to ensure products consistently meet regulatory requirements and customer expectations.
Required Qualifications
- Bachelor's degree in Food Science, Microbiology, Chemistry, Biology, Regulatory Affairs, Quality Assurance, or related discipline
- 5+ years in Quality Assurance or Regulatory Affairs within food, dietary supplements, or ingredient manufacturing/distribution
- 2+ years leading Quality or Regulatory teams
- Strong working knowledge of FDA, FSMA, FSVP, GMPs, HACCP, and supplier quality systems
- Experience managing customer audits and regulatory inspections
- Experience developing and improving Quality Management Systems
- Demonstrated experience using TraceGains for supplier qualification, document management, and customer technical documentation
Desired Qualifications
- Leadership & Coaching
- Strategic Thinking
- Regulatory Expertise
- Quality Systems Management
- Supplier Qualification and Maintenance
- Risk Assessment
- Root Cause Analysis
- CAPA Management
- Customer Management
- Project Management
- Cross-Functional Leadership
- Continuous Improvement
- Strong Communication
- Data-Driven Decision Making
- Change Management
- Execution and Accountability
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