Associate Manager - Food Safety and Validation

Role Summary

We are seeking a skilled and proactive Associate Manager - Food Safety and Validation to champion the safety, quality, and compliance of our infant formula products. This pivotal role involves managing food safety programs and leading validation processes, including equipment qualification, cleaning validation, and software validation, while ensuring compliance with global standards like FSSC 22000, BRC or SQF. Monday - Friday, 8am - 4pm.

• Food Safety Management:
  Develop and oversee infant formula-specific food safety programs, including HACCP, GMPs, and allergen control plans, ensuring alignment with FSSC 22000 certification requirements.
• Monitor compliance with global food safety standards such as the FDA's Infant Formula Act, Codex Alimentarius, FSMA, and FSSC 22000/BRC/SQF frameworks.
• Conduct routine food safety risk assessments and implement preventive controls to maintain the highest standards in infant formula production.
• Validation Oversight:
  Manage comprehensive validation processes for equipment critical to infant formula safety, including qualification protocols (IQ/OQ/PQ) in compliance with FSSC 22000’s systematic approach to validation.
• Oversee cleaning validation activities, ensuring hygiene standards meet or exceed FSSC 22000/BRC/SQF guidelines for infant formula manufacturing.
• Oversee software validation efforts, emphasizing accuracy, data integrity, and compliance for digital systems managing infant nutrition formulations.
• Maintain and update validation master plans, protocols, and reports to meet the rigorous demands of regulatory and certification requirements.
• Regulatory Compliance:
  Ensure all activities align with FSSC 22000/BRC/SQF, FDA's Good Manufacturing Practices for Infant Formula, FSMA, and other global regulations.
• Serve as a key contact during regulatory audits, certification assessments, and inspections, providing validation documentation and expert responses to inquiries.
• Training and Development:
  Design and implement FSSC 22000/BRC/SQF-focused training programs for production teams, covering food safety principles, validation protocols, and compliance requirements.
• Foster expertise in executing qualification and validation tasks aligned with FSSC 22000/BRC/SQF certification.
• Continuous Improvement:
  Collaborate with cross-functional teams to enhance safety and quality processes, driving compliance with FSSC 22000/BRC/SQF standards.
• Promote adoption of emerging technologies and industry best practices for improved nutritional quality assurance and operational efficiency.
• Data Analysis and Reporting:
  Analyze data from validation studies and safety monitoring programs to identify trends and ensure ongoing compliance with FSSC 22000 requirements.
• Prepare detailed technical reports and presentations for senior leadership and regulators, with a focus on infant nutrition standards and certification benchmarks.

• Required:
  
  Bachelor’s degree in food science, Microbiology, Chemistry, Engineering, or a related field.
• Required:
  
  5+ years of experience in food safety, quality assurance, or validation, preferably in the infant formula or infant nutrition industry.
• Required:
  
  In-depth understanding of FSSC 22000/BRC/SQF certification requirements and implementation in infant formula production.
• Required:
  
  Expertise in validation protocols (IQ/OQ/PQ), cleaning validation, and software qualification processes.
• Required:
  
  Strong knowledge of FDA, FSMA, Codex, and FSSC 22000/BRC/SQF compliance standards.
• Required:
  
  Exceptional analytical, organizational, and project management skills.
• Required:
  
  Effective communication and leadership abilities to manage interdisciplinary teams and complex projects.
• Preferred:
  Certification in food safety programs (e.g., HACCP, SQF) or FSSC 22000 training.

• Bachelor’s degree in food science, Microbiology, Chemistry, Engineering, or a related field

• Knowledge, experience, and skills with quality assurance functions. Strong involvement with industry professional associations is preferred. Network within the pharma industry and partner strategically with global regulators.
• Listening, negotiating and effective communication skills under pressure are highly preferred.
• Responsible for daily management of Quality Compliance and Quality Escalations. Develops and implements effective metrics and strategies.
• Directs and manages QMS processes and reporting requirements.
• Quality Compliance, Quality Inspection and Audit, QMR, QA, QC, QRM
• Expertise in applying predictive analytics and big data/artificial intelligence to create predictive indicators
• Supports Perrigo Quality Management Review Process