Quality Assurance & Regulatory Manager

Nura; Irvine (CA); On-site; USD 130,000 - 180,000; Full time

Job summary

NURA is seeking a Quality Assurance & Regulatory Manager to lead the QA and Regulatory teams in the US and China, driving QMS improvements and regulatory compliance programs. The role partners with operations, procurement, sales, and customer service to ensure products meet all requirements.

Reporting to the Director of Quality, you will translate strategy into execution, develop talent, and advance continuous improvement, with oversight of documentation, supplier quality, and customer

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.

Responsibilities

• Provide leadership and day-to-day management of QA and Regulatory functions.
• Lead QA, Documentation, and Regulatory departments across US and China.
• Maintain and improve the Quality Management System (QMS) and regulatory programs.
• Oversee supplier qualification, customer compliance requests, and documentation systems.

Skills

Quality Assurance

Regulatory Affairs

Leadership

Data-driven decisions

Education

Bachelor's degree in Life Sciences

Tools

TraceGains

Job 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, Complaint Handling & Resolution, Ingredient/Manufacturer/Facility regulatory documentation., etc.)
• Establish departmental KPIs and monitor performance against quality objectives.
• Lead management review activities and quality performance reporting.
• Drive continuous improvement initiatives using data and risk-based decision making.
• Standardize quality processes across U.S. and China operations.
• Ensure quality and regulatory activities are executed proactively, with clear ownership, timely communication, and defined completion timelines.

Regulatory & Compliance

• Ensure compliance with FDA, FSMA, FSVP, USDA Organic, Non-GMO Project, Kosher, Halal, SQF, customer-specific requirements, and other applicable regulations.
• Oversee regulatory documentation, technical documentation, and customer compliance requests.
• Review regulatory changes and implement appropriate internal actions.
• Lead regulatory assessments for new products and suppliers.
• Serve as the primary internal resource for regulatory interpretation and customer regulatory inquiries.

Supplier Quality Management

• Oversee the FSVP Program at NURA ensuring qualification activities are being maintained, documentation and assessments are being performed according to established SOPs, and compliance gaps are addressed immediately.
• Approve supplier qualification activities.
• Review supplier audits, risk assessments, CAPAs, and performance metrics.
• Drive supplier quality improvement initiatives.
• Escalate supplier quality concerns and monitor corrective actions.

Customer Quality Support

• Oversee customer questionnaires, technical documentation, specifications, COAs, allergen statements, regulatory forms, and certification requests, ensuring proper checks are in place and systematic improvement efforts are implemented to ensure documentation is current, accurate, and professionally answered.
• Lead customer audits and quality meetings.
• Provide technical guidance to Sales and Customer Service.
• Lead customer complaint investigations requiring Quality Assurance involvement ensuring prompt response, effective root cause analysis, corrective actions, and document closure.

Documentation & Quality Systems

• Ensure all controlled documents remain accurate, current, and compliant.
• Approve SOPs, work instructions, forms, and quality records.
• Lead document control, change control, and document retention programs.
• Improve document workflows and digital quality systems.
• Ensure consistency and version control across all technical documentation distributed internally and externally.

Product Safety & Risk Management

• Maintain HACCP, Food Safety Plan, Food Defense, Recall, Traceability, and Risk Assessment programs.
• Lead internal audits and regulatory inspections.
• Coordinate external certification audits.
• Ensure corrective and preventive actions are implemented effectively.

Team Leadership

• Recruit, coach, mentor, and develop Quality Assurance and Regulatory personnel.
• Conduct performance reviews and establish employee development plans.
• Foster accountability, ownership, urgency, collaboration, and continuous learning.
• Build cross-functional partnerships throughout the organization.
• Foster accountability, ownership, urgency, collaboration, professionalism and a proactive mindset.

Cross-Functional CollaborationPartner closely with:

• Quality Control
• Purchasing
• Logistics
• Warehouse Operations
• Sales
• Customer Service
• China Office
• Executive Leadership

Decision-Making Authority

• Approve supplier qualification status.
• Approve controlled quality documents.
• Approve regulatory documentation.
• Approve quality investigations and CAPAs.
• Recommend supplier disqualification when appropriate.
• Recommend product disposition for quality-related issues.
• Escalate significant business risks to the Director of Quality & Regulatory.

Key Performance Indicators:

• Audit Performances (Internal and External facilities). Successfully manage internal audits, supplier audits, customer audits, and third-party certification audits, with timely closure of findings and corrective actions.
• Complaint Closure Turn Around Time and Customer Management. Ensure customer complaints, investigations, root cause analysis, and corrective actions are completed accurately, communicated appropriately, and closed within established timeline.
• Document and Technical Requests closure time. Ensure customer questionnaires, specifications, regulatory documents, certifications, and technical requests are completed accurately, consistently, and within established turnaround times.
• Manufacturer engagement and development. Supplier qualification completed on schedule and supplier quality issues resolved.

Leadership:

• Team engagement
• Employee development
• Cross-functional collaboration
• Implementation of continuous improvement initiatives.

Qualifications

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