Oversee NURA’s Quality Assurance and Regulatory teams to maintain FDA/FSMA compliance, manage supplier audits, and lead continuous improvement of the QMS for food/supplement products.
Compensation
Not disclosed
Location
Irvine, California, United States
Work setup
Onsite
Seniority
Not specified
Employment
Not specified
Experience
2+ years
Category
Qa
Posted
Skills
corrective-action
regulatory-compliance
risk-assessment
root-cause-analysis
version-control
Must have
Education: Bachelor's degree in Food Science, Microbiology, Chemistry, Biology, Regulatory Affairs, Quality Assurance, or related discipline.
Experience
•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. Core Competencies
•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
Full description
The Quality Assurance & Regulatory Manager provides leadership and day-to-day management of NURA's Quality
Assurance and Regulatory functions while supporting the strategic direction established by the Director of Quality. This role is responsible for maintaining and continuously improving the Quality Management System (QMS), regulatory compliance programs, supplier qualification, customer technical support, documentation systems, and ingredient safety initiatives.
The position leads the Quality Assurance and Regulatory team while partnering closely with Quality Control, Operations,
Procurement, Sales, Customer Service, and the China Office to ensure products consistently meet regulatory requirements, customer expectations, and NURA's quality standards.
Reporting directly to the Director of Quality, this position translates strategic initiatives into day-to-day execution, develops departmental talent, drives continuous improvement, and serves as the primary leader for Quality Assurance and Regulatory activities.
Direct Reports:
•Quality Assurance & Regulatory Staff (US)
•Documentation and Quality Assurance Specialist Staff (China)
Primary Responsibilities:
Quality Management Leadership
•Lead the Quality Assurance, Documentation, and Regulatory departments in both the US and China Offices,
establishing priorities, workload, and performance expectations.
•Manage and continuously improve NURA's Quality Management System (QMS). NURA’s QMS includes but is not
limited to (NURA & Manufacturer Certification Maintenance, Ingredient and Supplier Quality Documentation,