Director, Quality & Regulatory Compliance (Manufacturing)

Essential Job Functions

• Establishes strategies, systems and controls to support company and customer objectives in the areas of quality assurance/compliance
• Ensures compliance to food safety regulations (e.g., FDA, USDA, FSMA, GFSI, ISO 13485) and packaging standards.
• Establishes and reports key quality performance metrics and provides leadership support to assigned sites to ensure scorecard objectives are met
• Develops and manages overarching quality framework, which utilizes assessment, training, and monitoring techniques to ensure compliance with federal, state and local laws and regulations, and independent agency standards
• Establishes and assures implementation of company-wide quality programs
• Provides overall guidance on elevated quality concerns and operational improvement opportunities working with key stakeholders and implementing corrective actions
• Oversees the external/internal audit processes and supports site quality representative responsible for executing any needed corrective action to address audit deficiencies
• Provides guidance on staffing, training, employee relations and performance management to develop and enhance the quality function, working closely with direct reports
• Maintains industry, professional and technical knowledge by networking, attending industry events, and reviewing professional publications

Education & Experience

• Bachelor's degree required
• Minimum of 6 years of relevant experience required

Knowledge, Skills & Abilities

• Regulatory Knowledge: Deep understanding of food safety regulations (e.g., FDA, USDA, FSMA, GFSI, ISO 13485) and packaging standards.
• Quality Assurance: Expertise in quality management systems (e.g., Document Controls, GFSI, HACCP) and continuous improvement methodologies. Strategic Thinking: Ability to develop and implement long-term strategies for quality and regulatory compliance.
• Team Leadership: Strong skills in leading, mentoring, and developing a high-performing quality and regulatory team.
• Change Management: Expertise in managing organizational change and driving continuous improvement initiatives.
• Communication Skills: Excellent verbal and written communication skills for effective interaction with internal teams, regulatory bodies, and external partners.
• Interdepartmental Collaboration: Ability to effectively collaborate with various departments such as design, production, supply chain, legal, risk, and marketing to ensure quality and regulatory standards are integrated into all processes.

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