Quality Assurance Manager

The Quality Assurance Manager is responsible to 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, regulatory compliance. The QA Manager 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.

• Promote a strong culture of quality and food safety through the site
• Be the site Preventive Controls Qualified Individual and manage 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, 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 and
• 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 Everwell 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.

• Lead, mentor, and develop a QA team and as needed, contractors (1-3 FTE)
• Perform staffing, training, performance management
• Foster a culture of quality, food safety, and compliance

• 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

• This role is based in Hadley, MA.May include travel up to 20%.

• Comprehensive insurance and benefits package, including health, vision, and dental
• 401K plan participation + yearly company match
• Paid vacation and sick-leave
• Invaluable learning experience at a high growth, science-first environment with strong fundamentals, a deep and innovative product pipeline, and a loyal customer base

Everwell Health is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status.