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Sports Nutrition, Health & Wellness, Food Supplements, E-commerce

Director of Quality, Dietary Supplements & Nutraceuticals

Mount Bethel, Pennsylvania, United StatesOnsiteFull TimeDirectorPosted 2 months ago

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Role summary

WIN Nutrition, a custom manufacturer of nutritional supplements, seeks a Director of Quality to lead quality systems, regulatory compliance, and supplier quality. This high-impact leadership role requires a professional with 5-10 years of experience in the dietary supplement or nutraceutical space, combining strategic management with hands-on oversight. Responsibilities include developing and maintaining the quality management system (FDA 21 CFR Part 111, cGMP), leading supplier qualification, conducting internal audits, and serving as the primary quality representative during inspections. The role collaborates cross-functionally to ensure product safety, efficacy, and compliance, driving continuous improvement through quality metrics.

About WIN Nutrition

WIN Nutrition is a custom manufacturer of nutritional supplement and consumer health products. We partner with brands from concept through commercialization, supporting formulation, manufacturing, packaging, and go-to-market execution through our network.

We are looking for a Director of Quality to lead and strengthen our quality systems, regulatory compliance, supplier quality oversight, and continuous improvement efforts across the business.

The Opportunity

This is a high-impact leadership role for an experienced quality professional in the dietary supplement or nutraceutical space. The Director of Quality will combine strategic quality management with hands-on quality oversight to help ensure product safety, efficacy, consistency, and compliance.

This role will work cross-functionally with quality, product development, production, regulatory, suppliers, and customers, while serving as a key representative during audits and inspections.

Key Responsibilities

  • Develop, implement, and maintain the company’s quality management system in accordance with FDA 21 CFR Part 111 and other applicable regulations
  • Ensure compliance with cGMP requirements, SOPs, and internal quality policies
  • Lead supplier qualification, supplier audits, and ongoing supplier quality assurance activities
  • Conduct internal audits and support audit readiness
  • Train staff on quality standards, policies, and procedures
  • Review and approve finished product Certificates of Analysis for customer delivery
  • Review raw material COAs prior to production
  • Oversee customer-requested qualification projects, including programs such as NSF Sport
  • Serve as the primary quality representative during FDA inspections and customer audits
  • Collaborate with R&D, production, and regulatory teams to ensure quality is built into all stages of product development and manufacturing
  • Oversee product stability programs and shelf-life determination
  • Review and approve test methods, analytical data, and specifications for raw materials, in-process materials, and finished products
  • Monitor product quality through routine testing and inspections as needed
  • Investigate deviations, out-of-specification results, and customer complaints
  • Manage the retain sample program, including organoleptic assessment of initial and subsequent production lots
  • Drive continuous improvement through tracking and trending of quality metrics, including complaints, deviations, and audit findings

Qualifications

  • Strong knowledge of FDA regulations, including 21 CFR Part 111, cGMP, and quality management system principles
  • Strong supplier quality, audit, and compliance experience
  • Strong leadership skills and ability to work cross-functionally
  • Excellent documentation, problem-solving, and communication skills
  • Proficiency with Microsoft Office Suite
  • Experience with SharePoint or other shared folder/document systems preferred
  • ERP experience is a plus

Education and Experience

  • Bachelor’s degree in Chemistry, Microbiology, Food Science, or a related field
  • 5 to 10 years of experience in dietary supplement or nutraceutical quality management and laboratory operations

Why WIN Nutrition

  • Work in a growing entrepreneurial environment
  • Help shape and lead quality systems in a high-impact role
  • Collaborate across product development, operations, and regulatory functions
  • Support innovative supplement and consumer health products from concept through commercialization

Apply today to join WIN Nutrition and help us continue building a best-in-class quality organization!

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