Job Description:
Summary
The RA/QA Compliance Manager is responsible for ensuring compliance with all applicable regulatory requirements, industry standards, and internal policies related to food safety, quality, and labeling. The primary objective is to develop and implement compliance programs, policies, and procedures, conduct audits and inspections, and provide guidance and training to employees to ensure adherence to all relevant regulations. This role collaborates closely with cross-functional teams, including quality assurance, production, supply chain, scientific affairs, and regulatory, to maintain and enhance compliance across the organization.
Responsibilities
Compliance Program Management
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Develop, implement, and maintain a comprehensive compliance program covering all relevant food safety, dietary supplement, quality, and labeling regulations, standards, and guidelines.
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Stay current on changes in regulations and industry best practices, updating compliance programs as needed.
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Establish policies, procedures, and control mechanisms to ensure consistent compliance.
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Conduct regular risk assessments and gap analyses; develop and implement corrective action plans.
Regulatory Compliance & Quality Management Systems (QMS)
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Monitor and interpret regulations from FDA, USDA, CFIA, and other regulatory authorities.
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Ensure compliance in food production, labeling, sanitation, ingredient specifications, and allergen management.
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Manage regulatory documentation, including ingredient declarations, nutritional information, certifications, and labeling claims.
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Conduct internal audits and inspections to ensure compliance; recommend corrective actions.
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Liaise with regulatory authorities, auditors, and certification bodies.
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Prepare for and manage external audits, inspections, and certifications; respond to findings and oversee corrective actions.
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Oversee development and maintenance of the QMS in compliance with FDA regulations (e.g., 21 CFR Part 111).
Product Compliance
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Review product formulations, labeling, and marketing materials for regulatory compliance.
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Ensure timely creation and approval of MMR/BPR documents in compliance with CFR requirements.
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Collaborate with R&D, Marketing, and Legal to assess regulatory risks.
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Maintain product registration and listings with regulatory authorities.
Quality Assurance
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Work with QA to maintain robust systems aligned with HACCP, GMP, ISO, and other standards.
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Ensure quality control measures across raw materials, in-process checks, and finished goods testing.
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Manage deviations, change requests, and corrective actions.
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Oversee complaint management, trend analysis, and customer feedback processes.
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Drive continuous improvement initiatives to enhance safety, quality, and customer satisfaction.
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Track and report KPI metrics for Quality Assurance and Regulatory Affairs.
Training & Communication
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Provide training to employees on compliance requirements, standards, and procedures.
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Develop and deliver compliance-related training programs.
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Promote a culture of compliance, accountability, and continuous improvement.
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Communicate regulatory updates and best practices to stakeholders.
Documentation & Recordkeeping
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Maintain accurate and up-to-date records of compliance activities.
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Ensure documentation is organized and audit-ready.
Additional duties as assigned.
Supervisory Responsibilities
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Yes, supervisory responsibilities.
Minimum Qualifications
Education
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Bachelors degree in food science, food technology, or a related field (Masters preferred).
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Certifications such as ISO-9001 Lead Auditor, FSMA/FSVP, HACCP, or equivalent are a plus.
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Equivalent combination of education and work experience may be considered.
Experience & Knowledge
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10+ years of compliance management experience in the dietary supplement and/or food industry.
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Strong understanding of FDA cGMP, DSHEA, FTC, food safety regulations, quality standards, and labeling requirements.
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Experience with regulatory bodies such as FDA, USDA, CFIA, and local authorities.
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Knowledge of QMS, HACCP, GMP, and ISO standards.
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Minimum 3 years of management experience leading regulatory or quality teams in a manufacturing environment.
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Strong knowledge of food production processes, sanitation, and supply chain operations.
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Exceptional attention to detail and organizational skills.
Skills/Abilities
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Problem solving, planning, and organizing.
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Strong verbal and written communication.
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Relationship management and time management.
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Ability to work across all organizational levels.
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Flexibility, adaptability, and multi-tasking ability.
Physical Demands
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Regularly requires talking, hearing, standing, walking, bending, kneeling, stooping, crouching, and climbing.
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Exposure to moving mechanical parts, strong fumes, loud noises, and occasional extreme temperatures.
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Ability to lift and move items up to 20 pounds.
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Vision requirements include close, distance, color, peripheral, depth perception, and focus adjustment.