Director of Quality and Regulatory Affairs

The role available with my client is a Director of Quality and Regulatory Affairs. They are looking for a candidate who will successfully run all things related to QA and Regulatory, ensuring that all requirements are met.

Client Details

My client is a company that focuses on nutraceutical manufacturing. They work with high quality ingredients and ensure that all products are made from the best ingredients in the most productive manner.

Description

• Oversee the QA department, including staff training, development, and performance management.
• Ensure all products and processes comply with FDA, cGMP, NSF, and other regulatory guidelines.
• Develop, implement, and maintain QMS protocols and SOPs for manufacturing, packaging, and distribution.
• Prepare for and lead regulatory audits and inspections, working to address findings and ensure corrective actions.
• Oversee product testing and release procedures, ensuring safety and efficacy of products in line with quality standards.
• Ensure accurate documentation of quality procedures, compliance records, and regulatory submissions.
• Partner with R&D, Operations, and Supply Chain teams to support product development and compliance.
• Identify opportunities for process improvements in QA and regulatory operations to increase efficiency and compliance.

Profile

• Bachelor's degree in a relevant scientific field (e.g., Biology, Chemistry, or Pharmacy); advanced degree preferred.
• 10+ years in quality assurance and regulatory roles within the nutraceutical, dietary supplement, or pharmaceutical industry.
• 5+ years in a management role
• Strong understanding of FDA, cGMP, NSF, DSHEA, and other relevant standards for nutraceuticals.
• Excellent leadership, communication, and project management skills; strong analytical and problem-solving abilities.
• ASQ or similar quality certifications are a plus.

Job Offer

• Great Benefits (Medical, Dental, Vision)
• 401k
• Generous PTO
• Career growth opportunity

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.