Director of Quality

Kalon Executive Search • Newark, NJ

8d • Onsite

About The Position

The Director of Quality will own the quality and compliance function for a growing dietary supplement manufacturer. The role combines setting quality strategy with hands-on oversight of daily execution to ensure products are safe, consistent, and compliant. The Director will collaborate with production, R&D, regulatory, procurement, and customers, and serve as the primary quality representative during regulatory inspections and customer audits. This is an in-person position just outside of New Jersey.

Requirements

• Working knowledge of FDA regulations and cGMP, including 21 CFR Part 111, and quality system principles.
• Hands-on experience with supplier qualification, auditing, and compliance.
• Leadership presence and ability to collaborate across departments.
• Strong written communication, documentation, and problem-solving skills.
• Comfort using Microsoft Office.
• Bachelor's degree in a scientific field such as chemistry, microbiology, or food science, or equivalent.
• 5 to 10 years of quality management experience in the dietary supplement or nutraceutical industry, including exposure to laboratory operations.

Nice To Haves

• Experience with SharePoint or similar document-sharing platforms.
• ERP familiarity.

Responsibilities

• Build, maintain, and continuously improve the quality management system in alignment with FDA dietary supplement cGMP regulations (21 CFR Part 111).
• Establish and enforce organization-wide SOPs and quality policies, and train teams on quality expectations.
• Own the supplier quality program, including approving vendors, conducting on-site and remote audits, and monitoring supplier performance.
• Lead internal audits and keep the facility inspection-ready.
• Serve as the lead quality contact for FDA inspections, third-party audits, and customer visits.
• Approve incoming material documentation before production use and release finished-product documentation to customers.
• Review and approve analytical methods, test data, and specifications for raw, in-process, and finished materials.
• Manage the stability and shelf-life program.
• Lead investigations into deviations, out-of-specification results, and customer complaints, and drive corrective and preventive actions.
• Manage the retain sample program, including sensory evaluation of production lots.
• Support customer-driven certification and qualification projects.
• Partner with R&D, production, and regulatory teams to incorporate quality from product development through manufacturing.
• Track and analyze quality metrics, including complaints, deviations, and audit findings, to drive continuous improvement.

What This Job Offers

• Job Type: Full-time
• Career Level: Director