Director of Quality, Dietary Supplements & Nutraceuticals
WIN Nutrition, Mount Bethel, PA, United States
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!
#J-18808-Ljbffr
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!
#J-18808-Ljbffr