Analysis Skills, Biology, Change Control, Chemistry, Code of Federal Regulations, Communication Skills, Continuous Improvement, Corrective Action, Cross-Functional, Customer Support/Service, Document Control, Documentation, Environmental Monitoring, FDA (Food and Drug Administration), FDA Requirements, Food Quality, Food Safety, Food Science, GMP (Good Manufacturing Practices), Internal Audit, Leadership, Maintain Compliance, Manufacturing, Mentoring, Microsoft Access Database, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Outsourcing, Performance Management, Pest Control, Problem Solving Skills, Process Improvement, Project Management Software, Project/Program Management, Quality Assurance, Quality Assurance Methodology, Quality Management, Quality Metrics, Quality Monitoring, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Root Cause Analysis, Safety Compliance, Sanitation, Shipping/Receiving, Standard Operating Procedures (SOP), Supply Chain, Traceability, Training Program, Validation Testing, Warehousing, Willing to Travel
Collinwood is assisting our client, a fast-growing manufacturer of nutraceutical ingredients, in their efforts to hire an experienced Food Quality Assurance Manager. In this role, you will lead all site-level quality and food safety operations at the Massachusetts manufacturing site, which produces annatto-derived ingredients through distillation. This role will serve as the site authority on quality systems and regulatory compliance, and you will oversee the implementation of the Food Safety Plan, ensuring compliance with all applicable FDA regulations (21 CFR 111 and 117) and manage the site Quality Management System (QMS). This position includes quality responsibilities for warehouse and production activities.
What you will be doing:
Quality Systems & Compliance
• Promote a strong culture of quality and food safety through the site
• Be the site Preventive Controls Qualified Individual and manage the Food Safety Plan in accordance with regulatory requirements
• Lead and 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 but not limited to sanitation validation and verification, internal inspections, and environmental monitoring.
• Manage recall program and ensure traceability is maintained throughout the supply chain.
• Manage contractors associated with food safety such as but not limited to Pest Control, Sanitation, uniforms.
• Review and approve production batch records, ensuring compliance/conformance with specifications and regulatory requirements
• Release, according to positive release procedure, raw materials, intermediate and finished products, including dietary supplements.
• Handle production nonconformities in accordance with site SOPs, and where applicable handle deviations, corrective and preventive actions.
• Lead investigations into incidents, quality and food safety issues and complaints and ensure implementation of corrective and preventive actions.
• Oversee QA processes related to on-site warehouse, including receiving, sampling, repacking, and storage
• Serve as point of contact for FDA inspections, state authorities, customer audits, and internal audits
• Drive site inspection readiness through walkthroughs, records review, and training
• Collaborate with cross-functional teams in Production, Laboratory, R&D, and Supply Chain to ensure quality and food safety standards are aligned and appropriately incorporated across the organization.
• Have quality oversight of any outsourced manufacturing and product transformation activities
• Have quality oversight of any outsourced manufacturing and product transformation activities
• Support health, quality, and supply chain departments with all supplier approval quality-related activities
• As applicable, handle all customer quality-related requests associated with the site and the products.
• Monitor and analyze quality metrics, driving root cause analysis and corrective actions as necessary to drive continuous improvement initiatives
• Track and report quality metrics; conduct management reviews
• Be the site quality and food safety representative in the Plant Leadership team.
Leadership & People Development
• Lead, mentor, and develop a QA team and, as needed, contractors (1-3 FTE)
• Perform staffing, training, and performance management
• Foster a culture of quality, food safety, and compliance
What we need from you:
• Bachelor's degree in Food Science, Chemistry, Biology, or related technical field (advanced degree preferred)
• Minimum 5-10 years of progressive quality assurance experience in food, dietary supplements, or ingredient manufacturing
• Deep working knowledge of 21 CFR 117 and familiarity with 21 CFR 111
• PCQI certified with demonstrated experience in overseeing product release, production records review, and QA in a manufacturing environment
• Excellent communication, documentation, and leadership skills
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Access); project management tools a plus.
• Excellent analytical, communication, problem-solving, and decision-making skills
Location and Travel:
• This role is based in Hadley, MA. May include travel up to 20%