Yellow Emperor
Regulatory and Quality Assurance Director
Yellow Emperor, Eugene, Oregon, United States, 97403
Regulatory and Quality Assurance Director Join to apply for the
Regulatory and Quality Assurance Director
role at
Yellow Emperor
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Regulatory and Quality Assurance Director
role at
Yellow Emperor Get AI-powered advice on this job and more exclusive features. Yellow Emperor is a leading liquid manufacturing partner for vitamin, herbal, nutraceutical, dietary, personal, and pet care products. What sets Yellow Emperor apart is the company’s approach to outstanding quality and their unique formula. Yellow Emperor holds tight to the firm belief that business can be a force for good, and we invite you to join us in growing this mission! JOB OBJECTIVE The Regulatory and Quality Assurance Director is responsible for overseeing regulatory compliance and quality systems across all aspects of dietary supplement manufacturing, labeling, and distribution. This role ensures products meet all applicable FDA, cGMP (21 CFR Part 111), and other regulatory requirements while maintaining robust quality assurance processes to ensure product safety, efficacy, and customer satisfaction. KEY RESPONSIBILITIES Regulatory Affairs Interpret and apply FDA regulations (21 CFR Part 111), FTC guidelines, DSHEA, and other applicable global regulatory requirements. Oversee product label reviews and claims substantiation to ensure compliance with FDA and FTC regulations. Serve as the primary liaison with regulatory agencies (FDA, NSF, OTCO, SQF, etc.) and respond to inquiries or inspections. Prepare and submit regulatory filings, including New Dietary Ingredient (NDI) notifications and GRAS submissions, as needed. Monitor regulatory developments and assess their impact on the company’s products and operations; ensure timely adaptation to changes in regulations. Collaborate with R&D, quality control, operations and sales teams to facilitate bringing on new customers and products. Quality Assurance Develop, implement, and maintain the Quality Management System (QMS) in accordance with cGMP (21 CFR Part 111) and SQF standards. Manage product testing programs, including raw material verification, finished product testing, stability studies, and third-party certifications. Investigate non-conformance, deviations, and customer complaints; lead Corrective and Preventive Actions (CAPA) processes. Maintain comprehensive quality documentation, including batch records, SOPs, training records, and audit reports. Train staff in regulatory and quality procedures, including cGMP compliance and industry’s best practices. SUPERVISORY RESPONSIBILITY ·This position supervises: Quality Control Manager. KEY QUALIFICATIONS A bachelor’s degree (BS) in Regulatory Affairs, Microbiology, Food Science, Nutrition, or a related field is required; an advanced degree is preferred A minimum of ten years of experience in regulatory affairs or compliance within the dietary supplement, food, or pharmaceutical industries. Demonstrated knowledge of FDA regulations, DSHEA, GMP, and other relevant compliance standards. Excellent analytical skills and attention to detail. Proven leadership and project management skills. Strong communication and interpersonal skills, with the ability to collaborate effectively across departments. Proficient in Microsoft Office, Word, Excel, and SharePoint. Ability to understand and learn new ERP programs such as FishBowl. SALARY AND BENEFITS ·$120k - $135k – Based on experience ·Two robust EAP programs ·Oregon Saves IRA ·Long-term and short-term disability ·Paid holidays, 8 bonus birthday hours ·Sick and personal paid time off This role is a non-exempt position with the company and is employed at will. We reserve the right to employ at will. This means that employment can be terminated, with or without cause, and with or without notice, at any time, at the option of the company or at the option of the employee. We are an equal opportunity employer committed to diversity and inclusion in our employment practices. We encourage all qualified people to apply regardless of race, color, religion, sex, sexual orientation, gender identity, veteran, justice impacted, and disability status. There is no guarantee of employment, and nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Employees must be able to perform the essential functions of the job with or without accommodation. Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionLegal IndustriesManufacturing Referrals increase your chances of interviewing at Yellow Emperor by 2x Sign in to set job alerts for “Regulatory Specialist” roles.Quality Assurance Compliance and Document Control SpecialistQuality Control Compliance Specialist (Construction Trainee)International Student and Scholar AdvisorInternational Student and Scholar Advisor We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Regulatory and Quality Assurance Director
role at
Yellow Emperor
A high number of candidates may make applications for this position, so make sure to send your CV and application through as soon as possible. Continue with Google Continue with Google Regulatory and Quality Assurance Director Join to apply for the
Regulatory and Quality Assurance Director
role at
Yellow Emperor Get AI-powered advice on this job and more exclusive features. Yellow Emperor is a leading liquid manufacturing partner for vitamin, herbal, nutraceutical, dietary, personal, and pet care products. What sets Yellow Emperor apart is the company’s approach to outstanding quality and their unique formula. Yellow Emperor holds tight to the firm belief that business can be a force for good, and we invite you to join us in growing this mission! JOB OBJECTIVE The Regulatory and Quality Assurance Director is responsible for overseeing regulatory compliance and quality systems across all aspects of dietary supplement manufacturing, labeling, and distribution. This role ensures products meet all applicable FDA, cGMP (21 CFR Part 111), and other regulatory requirements while maintaining robust quality assurance processes to ensure product safety, efficacy, and customer satisfaction. KEY RESPONSIBILITIES Regulatory Affairs Interpret and apply FDA regulations (21 CFR Part 111), FTC guidelines, DSHEA, and other applicable global regulatory requirements. Oversee product label reviews and claims substantiation to ensure compliance with FDA and FTC regulations. Serve as the primary liaison with regulatory agencies (FDA, NSF, OTCO, SQF, etc.) and respond to inquiries or inspections. Prepare and submit regulatory filings, including New Dietary Ingredient (NDI) notifications and GRAS submissions, as needed. Monitor regulatory developments and assess their impact on the company’s products and operations; ensure timely adaptation to changes in regulations. Collaborate with R&D, quality control, operations and sales teams to facilitate bringing on new customers and products. Quality Assurance Develop, implement, and maintain the Quality Management System (QMS) in accordance with cGMP (21 CFR Part 111) and SQF standards. Manage product testing programs, including raw material verification, finished product testing, stability studies, and third-party certifications. Investigate non-conformance, deviations, and customer complaints; lead Corrective and Preventive Actions (CAPA) processes. Maintain comprehensive quality documentation, including batch records, SOPs, training records, and audit reports. Train staff in regulatory and quality procedures, including cGMP compliance and industry’s best practices. SUPERVISORY RESPONSIBILITY ·This position supervises: Quality Control Manager. KEY QUALIFICATIONS A bachelor’s degree (BS) in Regulatory Affairs, Microbiology, Food Science, Nutrition, or a related field is required; an advanced degree is preferred A minimum of ten years of experience in regulatory affairs or compliance within the dietary supplement, food, or pharmaceutical industries. Demonstrated knowledge of FDA regulations, DSHEA, GMP, and other relevant compliance standards. Excellent analytical skills and attention to detail. Proven leadership and project management skills. Strong communication and interpersonal skills, with the ability to collaborate effectively across departments. Proficient in Microsoft Office, Word, Excel, and SharePoint. Ability to understand and learn new ERP programs such as FishBowl. SALARY AND BENEFITS ·$120k - $135k – Based on experience ·Two robust EAP programs ·Oregon Saves IRA ·Long-term and short-term disability ·Paid holidays, 8 bonus birthday hours ·Sick and personal paid time off This role is a non-exempt position with the company and is employed at will. We reserve the right to employ at will. This means that employment can be terminated, with or without cause, and with or without notice, at any time, at the option of the company or at the option of the employee. We are an equal opportunity employer committed to diversity and inclusion in our employment practices. We encourage all qualified people to apply regardless of race, color, religion, sex, sexual orientation, gender identity, veteran, justice impacted, and disability status. There is no guarantee of employment, and nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Employees must be able to perform the essential functions of the job with or without accommodation. Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionLegal IndustriesManufacturing Referrals increase your chances of interviewing at Yellow Emperor by 2x Sign in to set job alerts for “Regulatory Specialist” roles.Quality Assurance Compliance and Document Control SpecialistQuality Control Compliance Specialist (Construction Trainee)International Student and Scholar AdvisorInternational Student and Scholar Advisor We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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