Director of Quality

Director of Quality | Dietary Supplement Manufacturing

About the Role
We're partnering with a growing supplement manufacturer that is looking for a Director of Quality to own its quality and compliance function. You'll set the strategy and stay close to daily execution, making sure every product that ships is safe, consistent, and fully compliant. You'll work closely with production, R&D, regulatory, procurement, and customers, and you'll be the face of quality during regulatory inspections and customer audits.

** This is an in-person position just outside of New Jersey **

What You'll Do

• Build, maintain, and continuously strengthen the quality management system, ensuring alignment with FDA dietary supplement cGMP regulations (21 CFR Part 111)
• Establish and enforce SOPs and quality policies across the organization, and train teams on quality expectations
• Own the supplier quality program, including approval of new vendors, on-site and remote audits, and ongoing performance monitoring
• Lead internal audit activity and keep the facility inspection-ready at all times
• Act as the lead quality contact for FDA inspections, third-party audits, and customer visits
• Approve incoming material documentation before use in production and release finished-product documentation to customers
• Review and sign off on analytical methods, test data, and specifications across 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
• Run 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 so quality is built in from development through manufacturing
• Track and trend key quality metrics, such as complaints, deviations, and audit findings, to drive ongoing improvement

What You Bring

• Working knowledge of FDA regulations and cGMP, including 21 CFR Part 111, and sound quality system principles
• Hands-on experience with supplier qualification, auditing, and compliance
• Leadership presence and the ability to collaborate across departments
• Strong written communication, documentation, and problem-solving skills
• Comfort with Microsoft Office; experience with SharePoint or similar document-sharing platforms is a plus; ERP familiarity is helpful

Background

• Bachelor's degree in a scientific field such as chemistry, microbiology, or food science (or equivalent)
• 5 to 10 years in quality management in the dietary supplement or nutraceutical industry, including exposure to laboratory operations

Compensation: $140,000 - $165,000 

If this sounds like the position you have been waiting for, please apply using the online application or the link below. All inquiries are strictly confidential. Our focus is to assist you in making your best next career move, and we will not use your information for any other purpose.

Kalon Search is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

www.KalonSearch.com