Director - Quality, Food Safety & Regulatory

POSITION SUMMARY

The Director of Quality, Food Safety & Regulatory provides strategic leadership and governance for the organization's quality, food safety, regulatory compliance, and continuous improvement programs. The Director establishes and maintains company-wide systems designed to ensure products are safe, compliant, consistently manufactured, and capable of meeting customer and company requirements.

This position provides functional leadership across manufacturing locations and serves as a primary technical and regulatory resource to executive leadership, Operations, R&D, Procurement, Supply Chain, Engineering, Commercial teams, and site Quality organizations. The role is expected to operate at the Advanced-to-Expert competency levels defined in the company Quality career development model.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Quality & Food Safety Systems: Develop, implement, maintain, and continuously improve the corporate Quality and Food Safety Management System. Establish policies, standards, procedures, verification programs, performance expectations, and governance necessary to ensure consistent implementation across manufacturing facilities. Provide strategic leadership for applicable HACCP, FSMA, GMP, GFSI/FSSC 22000, and related food safety and quality systems.

Regulatory Compliance: Maintain organizational compliance with applicable FDA and other regulatory requirements. Interpret regulatory requirements, assess business impact, develop company-wide compliance strategies, and communicate requirements to affected functions. Serve as a principal company liaison with regulatory authorities and lead or support regulatory inspections, responses, corrective actions, and ongoing compliance initiatives.

Food Safety Risk Management: Provide leadership for identification, assessment, mitigation, escalation, and communication of significant food safety and quality risks. Ensure effective programs are maintained for allergen control, contaminant prevention, sanitation, environmental monitoring, microbiological control, supplier quality, traceability, preventive controls, and other applicable food safety hazards.

Processing & Technical Oversight: Provide technical leadership for beverage manufacturing processes and their impact on product safety, quality, and regulatory compliance. Evaluate processing deviations and significant technical issues involving pasteurization, sterilization, filling, packaging, sanitation, analytical testing, microbiological controls, and related manufacturing technologies.

Sanitation & Hygienic Controls: Establish corporate expectations for sanitation and cleaning programs, including CIP/SIP where applicable. Ensure appropriate validation and verification of cleaning effectiveness and provide leadership for the resolution of significant or recurring sanitation failures.

Supplier Quality Management: Develop and oversee the supplier quality strategy, including risk-based supplier approval, qualification, performance monitoring, traceability, supplier corrective actions, and escalation of significant supplier issues. Ensure supplier programs support food safety, regulatory, customer, and business requirements across multiple locations.

Labeling & Product Regulatory Compliance: Provide leadership and technical guidance for product labeling and regulatory compliance. Evaluate complex labeling requirements, claims, ingredient declarations, allergens, and other regulatory considerations, and coordinate specialized review when required.

Quality Management System Governance: Design and improve systems integrating quality, food safety, regulatory requirements, document control, deviations, CAPA, internal auditing, management review, change management, validation, verification, and continuous improvement.

Audits & Inspections: Provide leadership for regulatory inspections, certification audits, customer audits, and significant internal audits. Ensure findings are appropriately investigated, root causes identified, corrective actions implemented, and effectiveness verified. Identify systemic trends and drive corporate-level corrective action where needed.

Crisis Management: Lead or provide senior Quality/Food Safety/Regulatory direction during significant product safety, regulatory, recall, withdrawal, contamination, customer, or manufacturing events. Ensure effective investigation, risk assessment, decision-making, communication, documentation, and post-event review.

Problem Solving & Continuous Improvement: Establish a culture of structured problem solving and prevention. Lead complex investigations and promote methods such as root cause analysis, 5-Whys, Fishbone, FMEA, DMAIC, trend analysis, Lean, and Six Sigma principles where appropriate. Drive systemic corrective actions and sustainable improvement.

Quality Data & Performance Management: Establish quality and food safety KPIs and data collection systems that provide meaningful information to site and executive leadership. Analyze trends across facilities and use data to identify risk, prioritize resources, measure program effectiveness, and influence business strategy.

Management Review: Lead or support corporate Quality and Food Safety Management Review. Present performance, trends, regulatory compliance, audit results, customer issues, supplier performance, risks, objectives, resource requirements, and continuous improvement opportunities to senior leadership.

Customer Quality & Technical Support: Provide senior-level support for significant customer quality and food safety matters. Ensure concerns are effectively investigated and use customer feedback and complaint trends to identify systemic improvement opportunities.

People & Organizational Development: Develop Quality and Food Safety leadership capability across the organization. Coach and mentor Quality Managers and other leaders, establish competency expectations, identify development needs, support succession planning, and build long-term organizational capability.

Cross-Functional Leadership: Work collaboratively with Operations, R&D, Engineering, Supply Chain, Procurement, Sales, Marketing, Human Resources, and executive leadership. Influence business decisions so food safety, quality, and regulatory considerations are incorporated into new products, processes, equipment, suppliers, acquisitions, and operational changes.

Change Management: Champion organizational change affecting Quality, Food Safety, and Regulatory systems. Help plan transitions, communicate the purpose and requirements of changes, address resistance, and build organizational understanding and ownership.

DECISION-MAKING AUTHORITY

• Escalates significant food safety, quality, or regulatory risks to executive leadership and requires or recommends appropriate containment and corrective action within established company authority.
• Provides technical direction regarding product disposition, regulatory compliance, food safety risk, audit response, supplier quality, and corrective action.
• Participates in and provides Quality/Food Safety/Regulatory leadership for product hold, release, withdrawal, recall, and other significant risk-management decisions.
• Advises executive leadership on regulatory strategy, compliance risk, resources, and priorities affecting the organization.

EDUCATION AND EXPERIENCE

• Bachelor's degree in Food Science, Microbiology, Chemistry, Engineering, Quality, or a related scientific/technical discipline preferred; an equivalent combination of education and substantial directly relevant experience may be considered.
• Significant progressive experience in food or beverage Quality, Food Safety, and Regulatory leadership, including responsibility for manufacturing operations and leadership of Quality personnel.
• Multi-site, corporate, or enterprise-level quality leadership experience strongly preferred.
• Demonstrated experience with regulatory compliance, food safety systems, audits, crisis management, supplier quality, customer requirements, continuous improvement, and organizational leadership.

KNOWLEDGE AND TECHNICAL QUALIFICATIONS

• Strong working knowledge of applicable FDA food regulations and food safety requirements, including 21 CFR requirements relevant to the company portfolio.
• Substantial knowledge of HACCP, FSMA preventive controls, GMPs, GFSI-recognized food safety management systems, sanitation, allergen management, environmental monitoring, microbiological controls, supplier quality, labeling, traceability, recall/withdrawal management, and risk assessment.
• Experience with beverage processing and packaging technologies such as pasteurization, hot-fill, aseptic processing, low-acid/acidified foods, preserved beverages, refrigerated products, powders, and bag-in-box systems is highly desirable where applicable to the manufacturing network.
• Ability to interpret analytical, microbiological, process, audit, complaint, supplier, and quality performance data and convert it into actionable business decisions.
• Working knowledge of ERP/LIMS or related quality data systems sufficient to support traceability, reporting, trending, and data integrity.

LEADERSHIP EXPECTATIONS

The Director is expected to operate beyond individual-site compliance and build systems that improve performance across the organization. Success requires the ability to influence senior leadership, develop other Quality leaders, translate regulatory and technical requirements into practical business controls, recognize systemic risk across facilities, and make sound decisions during high-pressure food safety or regulatory situations.

The role is accountable for moving the organization from reactive correction toward risk prevention, standardization, data-driven decision-making, and continuous improvement while maintaining strong customer and regulatory relationships.

MEASURES OF SUCCESS

• Effectiveness and maturity of the Quality and Food Safety Management System.
• Regulatory, certification, and customer audit performance and timely closure of findings.
• Food safety and quality incident trends, recurrence reduction, and CAPA effectiveness.
• Customer complaint trends and customer quality performance.
• Supplier quality performance and effectiveness of supplier corrective actions.
• Quality KPI performance, data quality, and effectiveness of executive management review.
• Successful implementation of corporate quality, food safety, and regulatory initiatives.
• Development, engagement, and succession readiness of Quality leadership talent.

PHYSICAL / WORK REQUIREMENTS

This position may require regular presence in manufacturing environments, walking production and warehouse areas, use of required personal protective equipment, and periodic travel to company facilities, suppliers, customers, laboratories, or regulatory/audit activities. Specific requirements should be aligned with the final work location and company HR standards.