What are the responsibilities and job description for the Senior Quality Assurance Manager position at Yellow Emperor?
About the Company
Yellow Emperor is a leading liquid manufacturing partner for various health and wellness products. We prioritize quality and innovation, striving to make a positive impact through our business practices.
Job Summary
The Senior Quality Assurance Manager leads our regulatory affairs efforts to ensure compliance with applicable laws and regulations. This role involves developing strategies, managing submissions, and collaborating with departments to maintain product safety and efficacy.
Key Responsibilities
- Lead the Quality Department in overall function and decision-making.
- Develop and implement regulatory compliance strategies for dietary supplement products.
- Oversee regulatory document preparation, submission, and maintenance.
- Monitor regulatory developments and adapt to changes.
- Collaborate with cross-functional teams to ensure regulatory compliance.
- Conduct training sessions on regulatory compliance and best practices.
- Serve as primary contact for regulatory agencies.
- Develop comprehensive regulatory compliance policies and procedures.
- Lead audit preparations and ensure findings are addressed promptly.
- Manage risk assessments and develop mitigation strategies.
- Oversee internal and external audits and quality control checks.
- Ensure financial objectives are met by preparing the Quality budget.
Key Qualifications
- Bachelor's degree in Regulatory Affairs, Microbiology, Food Science, or a related field.
- At least ten years of experience in regulatory affairs or compliance.
- Demonstrated knowledge of FDA regulations and compliance standards.
- Excellent analytical skills and attention to detail.
- Proven leadership and project management skills.
- Strong communication and interpersonal skills.
- Proficient in Microsoft Office and Excel.
Requirements
- Must be able to work onsite.
- Must currently be available to commute to work site.