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Job Title: Director of Quality and Regulatory
We are seeking an experienced Director of Quality and Regulatory to lead quality and regulatory functions for a leading nutraceutical contract manufacturer. This role will be responsible for ensuring compliance with all relevant regulations (21 CFR Part 111 & 117), overseeing quality systems, and driving a culture of continuous improvement.
Key Responsibilities
- Establish, implement, and manage regulatory, quality assurance, quality control, and complaint handling functions to ensure the quality, safety, and reliability of all products.
- Oversee QA/QC processes and Quality Systems to ensure compliance with FDA and other regulatory authorities.
- Identify and implement improvements to enhance product quality, streamline processes, and optimize cost efficiency.
- Lead, mentor, and develop the quality and regulatory team.
- Serve as Management Representative and Person Responsible for Regulatory Compliance.
Qualifications
- Bachelors degree in Life Sciences or related field required; advanced degree or Quality/Regulatory certification preferred.
- 10+ years of experience in the nutraceutical industry , with proven leadership and management experience.
- In-depth knowledge of FDA regulations, cGMP, 21 CFR Part 11, 111, and 117.
- Extensive experience working with FDA, Notified Bodies, and regulatory auditors.
- Strong background in Quality Systems, regulatory compliance, complaint handling, and risk management.
- Excellent leadership, communication, and problem-solving skills.
Equal Opportunity Statement
We are committed to diversity and inclusivity in our hiring practices.
Interested? Apply Now or reach out to Tore Jordan-Wright - ,
Seniority level
Seniority level
Director
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance-
Industries
Food and Beverage Manufacturing and Wellness and Fitness Services
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