Director of Quality and Regulatory Compliance

Job Summary

We are seeking a Director of Quality and Regulatory Compliance to lead the development, implementation, and continuous improvement of our Quality Management System (QMS). This pivotal role ensures that all operations, from raw materials to finished products, meet regulatory requirements and industry standards. The Director will oversee all Quality Assurance (QA) and Quality Control (QC) activities across the manufacturing process, driving operational efficiency, product integrity, and compliance. Additionally, the Director will maintain regulatory certifications, ensure adherence to food safety and quality standards, and lead the company's ongoing efforts to enhance quality systems and practices.

Key Responsibilities:

• Lead and oversee the Quality Assurance and Quality Control departments, including managing supervisory staff and ensuring department alignment with company objectives.
• Develop and implement quality assurance policies, standard operating procedures (SOPs), and best practices to maintain product quality and regulatory compliance.
• Evaluate production operations at a strategic level, ensuring that all products meet quality, safety, and performance specifications.
• Collaborate with executive leadership and production teams to establish and maintain quality benchmarks and continuous improvement initiatives.
• Ensure compliance with FDA regulations, cGMP standards, and third-party certifications (e.g., UL, NSF, Organic, SQF).
• Serve as the SQF Primary Practitioner, ensuring compliance with SQF food safety and quality management systems.
• Oversee internal and external audits, customer inspections, and regulatory agency interactions.
• Develop and execute training programs for quality assurance and production staff to ensure adherence to quality standards and continuous improvement.
• Analyze quality data and implement corrective and preventive actions (CAPAs) to address deviations and drive operational improvements.
• Review and approve quality control documentation, including checklists, logs, reports, and batch records, ensuring accuracy and completeness.
• Conduct random inspections and oversee quality control testing processes to verify compliance with established standards.
• Report quality metrics, trends, and operational updates to executive leadership, providing data-driven recommendations for process enhancements.
• Lead investigations of product complaints and quality issues, ensuring timely resolution and implementation of corrective actions.
• Oversee the supplier quality management program, ensuring raw material vendors comply with company standards and regulatory requirements.
• Stay updated on industry regulations, trends, and emerging quality standards, proactively implementing necessary changes within the company.

Qualifications & Experience:

Education:

• Bachelor’s degree in Engineering, Food Science, Chemistry, Biology, or a related industrial, scientific, or business field required; Master’s degree preferred.

Experience:

• 10 years of experience in quality assurance/control, preferably within the dietary supplement, pharmaceutical, or food manufacturing industry.
• Minimum 5 years in a senior leadership or quality management role.
• Extensive knowledge of cGMP, FDA regulations, SQF, NSF, UL, and other relevant industry standards.
• Experience managing audits, regulatory inspections, and third-party certification programs.
• Proven ability to lead teams, drive process improvements, and implement quality management systems (QMS).

Skills & Competencies:

• Strong leadership and team management capabilities.
• Excellent verbal and written communication skills, with the ability to train and mentor staff at all levels.
• Deep understanding of quality control methodologies, risk assessment, and process validation.
• Strong analytical and problem-solving skills, with attention to detail and data-driven decision-making.
• Proficiency in Microsoft Office Suite or Google Workspace, quality management software, and statistical analysis tools.
• Ability to work cross-functionally with operations, R&D, and supply chain teams to ensure quality is integrated into all processes.

Physical Requirements

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.