Director of Quality

The job overview for the Director of Quality position at ByHeart is to lead and direct a team in ensuring effective quality execution, continuous improvement, and regulatory compliance for infant formula. The role involves building and maintaining a culture of food safety and quality within the facility, developing and implementing quality systems and training programs, and serving as a subject matter expert on all aspects of quality assurance. The Director of Quality is also responsible for overseeing USFDA inspections, change management programs, and defining facility processes to ensure finished product safety and quality.

• Direct and lead a team to ensure effective quality execution, continuous improvement, and infant formula regulatory compliance
• Build and maintain an effective culture of food safety and quality within the facility
• Develop and maintain facility systems and processes to ensure finished product is food safe and meets specifications
• Drive quality ownership at all levels and promote a quality culture and mindset among employees
• Develop quality systems, training programs, and consistent practices aligned with corporate quality policy
• Serve as a subject matter expert and thought leader on all aspects of quality assurance
• Lead USFDA inspections and resolve observations with the agency
• Oversee change management program to ensure compliance with laws, regulations, and corporate directives
• Define and implement facility processes to ensure finished product safety and quality
• Ensure compliance with regulatory requirements for ingredients and packaging

• Experience in quality execution, continuous improvement, and infant formula regulatory compliance
• Ability to provide leadership and drive positive change within the facility
• Knowledge of food safety and quality systems and processes
• Highly organized and effective communicator
• Inquisitive mind with the capacity for investigation and solution-based decision making
• Experience in driving quality ownership and fostering a quality culture
• Expertise in cGMP compliance, Environmental Monitoring and Hygienic Zoning, Statistical Process Control, Continuous improvement, Laboratory Operations, PX Measures, procedural document control, release and stability testing protocols, root cause problem solving, and new product development- quality assurance
• Experience leading USFDA inspections and resolving observations
• Familiarity with change management programs and compliance with related laws, regulations, and corporate directives
• Knowledge of facility processes to ensure finished product safety and quality, including compliance with regulatory requirements for ingredients and packaging

• Fully comprehensive benefits package
• Flexibility to achieve personal work-life balance