ABOUT THE COMPANY
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 Senior Quality Assurance Manager leads our regulatory affairs initiatives to ensure that our products meet all applicable laws and regulations. This role will involve developing compliance strategies, managing regulatory submissions, and collaborating with various departments to maintain our product safety and efficacy commitment. Regulatory bodies include the FDA, USDA, Department of Agriculture, and OTCO. This position oversees all supplier and material specification approvals for safe food labeling and manufacturing practices.
KEY RESPONSIBILITIES
- Leads the Quality Department in overall function and final decision-making.
- Oversee the development of quality policies, systems, and procedures.
- Develop and implement regulatory compliance strategies for dietary supplement products in accordance with FDA regulations, DSHEA, and other relevant guidelines.
- Oversee the preparation, submission, and maintenance of all regulatory documents, including product registrations, labeling, and advertising.
- Monitor regulatory developments and assess their impact on the company's products and operations; ensure timely adaptation to regulation changes.
- Collaborate with research and development, quality control, operations, and sales teams to ensure that existing and new product formulations, labeling, and claims comply with applicable regulations.
- Conduct training sessions and workshops for staff on regulatory compliance, industry standards, and best practices.
- Serve as the primary contact for regulatory agencies and manage all interactions, inspections, and audits.
- Develop and maintain comprehensive regulatory compliance policies and procedures.
- Lead the preparation for regulatory audits and inspections; ensure all findings are addressed promptly and effectively to ensure the company maintains certifications.
- Conduct risk assessments and develop mitigation strategies for compliance-related issues.
- Manage internal and external audits and quality control checks.
- Oversee Corrective Action Preventive Action (CAPA) policy and procedures, including root cause analysis.
- Achieves financial objectives by preparing the Quality budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
KEY QUALIFICATIONS
- Bachelor's degree (BS) in Regulatory Affairs, Microbiology, Food Science, Nutrition, or a related field is required; advanced degree preferred
- At least 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, and Excel
REQUIREMENTS
- Must be able to work onsite and in person.
- Must currently be available to commute to work site.
SALARY AND BENEFITS
- $110k - $120k – Based on experience
- Medical, dental, vision, EAP
- Oregon Saves IRA
- Life Insurance, long-term and short-term disability
- Paid holidays
- Sick and personal paid time off
This role is an exempt position with the company and is employed at will.
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.