Position Summary:
The Director of Quality will oversee and manage the quality assurance and control processes for both the lubricants and dietary supplements divisions. This role involves ensuring compliance with regulatory standards, implementing quality systems, and leading continuous improvement initiatives. The Director of Quality will report directly to the General Manager and collaborate closely with cross-functional teams to maintain the highest quality standards.
• Quality System Management:
o Develop, implement, and maintain quality management systems in compliance with FDA regulations (21 CFR Part 111 for dietary supplements and 21 CFR Part 820 for lubricants) and ISO standards.
o Ensure all products meet quality and safety standards.
o Oversee document control and ensure efficient management of quality documentation.
• Regulatory Compliance:
o Serve as the primary contact for regulatory bodies, including the FDA.
o Manage product registrations and regulatory submissions for domestic and international markets.
o Prepare for and lead regulatory audits and inspections.
• Continuous Improvement:
o Lead quality improvement initiatives using data-driven methods.
o Conduct root cause analysis and implement corrective and preventive actions (CAPA).
o Monitor and report on key quality metrics and performance indicators.
