Job Title: QA Quality Engineer – External (Food Safety / PCQI)

Position Summary

This role is responsible for external Quality Assurance activities, with a strong emphasis on food safety, FSMA compliance, and PCQI oversight. The position ensures that contract manufacturers (CMOs), suppliers, and service providers meet FDA, EMA, and food safety regulatory requirements, as well as internal quality standards.

This individual will serve as a key quality partner in overseeing supplier qualification, audit readiness, and compliance within food, feed, and related regulated product categories. Periodic domestic and international travel is expected; a valid passport is required

Key Responsibilities

GMP & Food Safety Compliance (CMOs/Suppliers)

• Ensure suppliers meet all regulatory and internal standards, including FDA, EMA, and FSMA requirements
  

• Lead and support supplier qualification activities in alignment with Preventive Controls for Human/Animal Food
  

• Conduct and support risk-based audits, with focus on food safety systems and hazard controls
  

• Maintain audit schedules and ensure timely execution
  

• Monitor and adapt to regulatory changes, ensuring ongoing compliance
  

• Support new product launches involving food/feed or combination products

Expected Outcome:
Robust supplier qualification program aligned with GMP and FSMA/PCQI requirements

Quality Assurance Oversight

• Review and approve deviations, OOS/OOT investigations, change controls, and batch documentation
  

• Evaluate supplier performance trends, including food safety and quality metrics
  

• Track and verify effectiveness of corrective actions (SCARs)
  

• Support management of Approved Supplier List (ASL)
  

• Assess and mitigate risks related to quality agreements, validation, and product lifecycle activities

Expected Outcome:
Proactive risk management and strong supplier quality performance

Quality Planning & Continuous Improvement

• Support development and maintenance of food safety plans and supplier controls
  

• Drive continuous improvement initiatives related to quality and compliance
  

• Partner cross-functionally with Regulatory, Clinical, Quality Risk Management, and Drug Safety teams
  

• Support supplier-related changes, validation reviews, and quality system improvements
  

• Present quality metrics and compliance updates to leadership

Expected Outcome:
Sustained compliance and continuous improvement in food safety and quality systems

Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, Food Science, or related field
  

• Minimum 5+ years in FDA-regulated environment, with strong food safety/FSMA experience
  

• PCQI certification preferred
  

• Strong knowledge of FSMA, HACCP, and GMP regulations
  

• Experience auditing food/feed manufacturers and suppliers
  

• Familiarity with both pharmaceutical and food regulatory frameworks preferred

Key Skills

• Expertise in food safety systems and preventive controls
  

• Strong auditing and supplier management experience
  

• Risk assessment and problem-solving skills
  

• Effective cross-functional collaboration
  

• Ability to influence without authority and communicate with global stakeholders

10186372