Job Title: Quality Manager

As a Quality Manager, you will lead all site-level quality and food safety operations at our Massachusetts manufacturing site, which produces annatto-derived ingredients through distillation. You will serve as the site authority on quality systems and regulatory compliance. Your key responsibilities include overseeing the implementation of the Food Safety Plan, ensuring compliance with FDA regulations (21 CFR 111 and 117), and managing the site Quality Management System (QMS). You will also manage quality responsibilities for warehouse and production activities, oversee quality-related activities with co-manufacturers, and be responsible for supply chain preventive control, including approval and Foreign Supplier Verification Program (FSVP) compliance.

• Promote a strong culture of quality and food safety throughout the site.
• Serve as the site Preventive Controls Qualified Individual and manage the Food Safety Plan in accordance with regulatory requirements.
• Manage site preventive controls-based Food Safety and Quality Management System (FSQMS), including SOPs, change control, training, and document control.
• Oversee training programs for GMPs, HACCP/Food Safety, and Food Defense/Food Fraud.
• Manage validation and verification activities of the site, including sanitation validation and verification, internal inspections, and environmental monitoring.
• Manage the recall program and ensure traceability is maintained throughout the supply chain.
• Manage contractors associated with food safety, such as pest control, sanitation, and uniforms.
• Review and approve production batch records, ensuring compliance with specifications and regulatory requirements.
• Handle production nonconformities in accordance with site SOPs, and handle deviations, corrective and preventive actions.
• Lead investigations into incidents, quality issues, and complaints.
• Oversee QA processes related to on-site warehouse, including receiving, sampling, repacking, and storage.

• Quality assurance
• Quality control
• Quality management
• Food safety
• Deep working knowledge of 21 CFR 117
• Familiarity with 21 CFR 111

• Bachelor’s degree in Food Science, Chemistry, Biology, or related technical field (advanced degree preferred)
• Minimum 10 years of progressive quality assurance experience in food, dietary supplements, or ingredient manufacturing
• PCQI certified with demonstrated experience in overseeing product release, production records review, and QA in a manufacturing environment
• Knowledge of supplier quality management and FSVP requirements
• Excellent communication, documentation, and leadership skills
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Access); project management tools a plus
• Excellent analytical, communication, and problem-solving skills

This role is based on-site with work hours from Monday to Friday, 8:30am-4:30pm.

This is a Permanent position based out of Hadley, Massachusetts.