Regulatory and Quality Assurance Director
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Regulatory and Quality Assurance Director
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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 companys 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 companys 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 industrys best practices.
SUPERVISORY RESPONSIBILITY
This position supervises: Quality Control Manager.
KEY QUALIFICATIONS
- A bachelors 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 managements 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 level
Director
Employment type
Employment type
Full-time
Job function
Job function
Legal-
Industries
Manufacturing
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