Head of Quality & Regulatory Affairs

Kalon Executive Search; Carson (CA); On-site; USD 140,000 - 180,000; Full time

Job summary

Kalon Executive Search is seeking a Director of Quality & Regulatory Affairs who will provide strategic and operational leadership in Quality Assurance, Quality Control, Regulatory Affairs, and Product Development. The ideal candidate will have over 10 years of relevant experience and a strong understanding of FDA regulations. This in-person position is located in Carson, CA.

The successful candidate is a hands-on leader, dedicated to quality and regulatory excellence, and skilled in fostering a culture of continuous improvement. Compensation is between $140,000 - $180,000 plus benefits.

Qualifications

• Bachelor's degree in Chemistry, Biology, Food Science, Pharmaceutical Sciences, or a related scientific discipline; advanced degree preferred.
• 10+ years of progressive leadership experience within dietary supplements, nutraceuticals, pharmaceuticals, food, or another regulated manufacturing environment.
• Proven expertise in Quality Assurance, Quality Control, Regulatory Affairs, and cGMP compliance.
• Strong knowledge of FDA regulations, quality systems, audit management, and risk-based quality approaches.
• Experience leading teams in manufacturing environments involving tablets, capsules, powders, or similar dosage forms is highly preferred.
• Strong analytical chemistry and laboratory operations background.
• Demonstrated success building and improving quality systems, processes, and organizational performance.
• Excellent leadership, communication, problem-solving, and stakeholder management skills.

Responsibilities

• Lead and oversee Quality Assurance, Quality Control, Regulatory Affairs, and Formulation teams.
• Ensure compliance with cGMP regulations, FDA requirements, customer standards, and industry best practices.
• Develop, implement, and continuously improve quality systems, policies, procedures, and documentation.
• Direct investigations related to nonconformances, deviations, CAPAs, customer complaints, and quality events.
• Maintain inspection readiness and serve as a key leader during customer, regulatory, and third-party audits.
• Establish and monitor key quality metrics and KPIs to drive operational excellence and continuous improvement.
• Provide technical and regulatory guidance to internal teams and external customers.
• Partner cross-functionally with Manufacturing, Operations, Supply Chain, R&D, and Commercial teams to support business objectives.
• Oversee environmental compliance initiatives and ensure adherence to applicable regulations.
• Support analytical methods development, laboratory operations, and quality testing programs.
• Mentor, develop, and lead high-performing quality and regulatory teams.

Job description

Kalon Executive Search is seeking a Director of Quality & Regulatory Affairs who will provide strategic and operational leadership in Quality Assurance, Quality Control, Regulatory Affairs, and Product Development. The ideal candidate will have over 10 years of relevant experience and a strong understanding of FDA regulations. This in-person position is located in Carson, CA.

The successful candidate is a hands-on leader, dedicated to quality and regulatory excellence, and skilled in fostering a culture of continuous improvement. Compensation is between $140,000 - $180,000 plus benefits.