Food Quality Assurance Manager

About the role

The Quality Assurance Manager leads all site-level quality and food safety operations at a Massachusetts manufacturing facility that produces annatto-derived ingredients through distillation. This role serves as the site authority on quality systems and regulatory compliance, oversees the implementation and maintenance of the Food Safety Plan, and ensures adherence to applicable FDA regulations (21 CFR 111 and 117).

Responsibilities

• Lead all site-level quality assurance and food safety operations for a manufacturing facility producing annatto-derived ingredients through distillation.
• Serve as the site authority on quality systems and regulatory compliance, ensuring alignment with internal policies and external regulatory requirements.
• Oversee the implementation, maintenance, and continuous improvement of the Food Safety Plan in compliance with FDA regulations, including 21 CFR 111 and 21 CFR 117.
• Manage and maintain the site Quality Management System (QMS), ensuring effective document control, standard operating procedures (SOPs), and quality records.
• Ensure compliance with Good Manufacturing Practices (GMP) and applicable regulatory standards across production and warehouse operations.
• Oversee quality responsibilities for warehouse and production activities, including inspection, in-process checks, and final product quality verification.
• Direct and review batch records and production records to support accurate product release and traceability.
• Lead and coordinate internal and external quality audits, including preparation, execution, response, and follow-up on corrective and preventive actions (CAPA).
• Implement, monitor, and improve CAPA processes to address nonconformances and drive sustainable quality improvements.
• Oversee laboratory-related quality activities, including testing, data review, and verification of food quality and safety parameters.
• Ensure effective food safety and HACCP-related practices are implemented, monitored, and documented throughout manufacturing and warehousing operations.
• Collaborate closely with production and warehouse teams to support compliant and efficient food manufacturing processes.
• Monitor and verify compliance with regulatory requirements, customer specifications, and internal quality standards for all products.
• Perform and oversee quality checks, inspections, and data entry related to quality metrics, ensuring accuracy and completeness of records.
• Provide leadership, training, and guidance to staff on quality, food safety, GMP, and regulatory expectations.
• Communicate clearly and effectively with cross-functional teams to resolve quality issues and support continuous improvement initiatives.
• Utilize analytical, problem-solving, and decision-making skills to investigate quality deviations and implement effective solutions.
• Use Microsoft Office and project management tools to manage documentation, reporting, and quality-related projects.
• Act as the primary quality leader for the facility, overseeing the entire site’s quality and food safety performance.

Qualifications

• Bachelor’s degree in Food Science, Chemistry, Biology, or a related technical field.
• Advanced degree in a relevant technical discipline preferred.
• Minimum 5–10 years of progressive quality assurance experience in food, dietary supplements, or ingredient manufacturing.
• Deep working knowledge of FDA regulation 21 CFR 117 and familiarity with 21 CFR 111.
• Proven experience with quality assurance in a manufacturing environment, including product release and production records review.
• PCQI (Preventive Controls Qualified Individual) certification with demonstrated experience in overseeing food safety and product release.
• Strong understanding of quality assurance, quality control, and quality management principles in food or ingredient manufacturing.
• Hands-on experience with food safety programs, including HACCP and GMP implementation.
• Experience with SOP development and management, CAPA processes, audits, batch record review, and document control.
• Knowledge of laboratory practices related to food science, chemistry, and biology as they pertain to quality and food safety.
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Access.
• Excellent analytical, problem-solving, and decision-making skills applied in a quality and regulatory context.
• Strong communication skills, both written and verbal, with the ability to document clearly and present information effectively.
• Demonstrated leadership skills with the ability to guide, influence, and support cross-functional teams.
• Experience in food manufacturing, food quality, and food safety compliance within a regulated environment.
• Familiarity with regulatory compliance requirements for food, dietary supplements, or ingredient manufacturing.

Skills

• Bachelor’s degree in Food Science, Chemistry, Biology, or a related technical field.
• Advanced degree in a relevant technical discipline preferred.
• Minimum 5–10 years of progressive quality assurance experience in food, dietary supplements, or ingredient manufacturing.
• Deep working knowledge of FDA regulation 21 CFR 117 and familiarity with 21 CFR 111.
• Proven experience with quality assurance in a manufacturing environment, including product release and production records review.
• PCQI (Preventive Controls Qualified Individual) certification with demonstrated experience in overseeing food safety and product release.
• Strong understanding of quality assurance, quality control, and quality management principles in food or ingredient manufacturing.
• Hands-on experience with food safety programs, including HACCP and GMP implementation.
• Experience with SOP development and management, CAPA processes, audits, batch record review, and document control.
• Knowledge of laboratory practices related to food science, chemistry, and biology as they pertain to quality and food safety.
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Access.
• Excellent analytical, problem-solving, and decision-making skills applied in a quality and regulatory context.
• Strong communication skills, both written and verbal, with the ability to document clearly and present information effectively.
• Demonstrated leadership skills with the ability to guide, influence, and support cross-functional teams.
• Experience in food manufacturing, food quality, and food safety compliance within a regulated environment.
• Familiarity with regulatory compliance requirements for food, dietary supplements, or ingredient manufacturing.