Education: Minimum Bachelor Degree in a scientific or technical field; graduate degree desired.
Experience: 10+ years’ experience in a Quality and/or Regulatory management position in food manufacturing.
Summary: This position is responsible for managing the Quality Management System designed to assure the products manufactured in the facilities comply with all Regulatory, Food Safety and Quality Specification requirements.
Essential Functions:
This position is responsible for:
1. Responsible for regulatory compliance with: FDA, USDA, DHS, domestic and foreign regulations.
2. Responsible for interactions with applicable regulating agencies, business partners and customers regarding product compliance domestically; coordinates with international business and local regulatory staff to ensure compliance to meet and exceed customer specifications.
3. Management responsibility for developing and implementing company Quality Systems; represents company for all audits by regulatory agency, third party audits, and customer inspections.
4. Responsible for assuring compliance of products manufactured in California based plants, implications include assuring control requirements are met and appropriate documentation is maintained in support of customer specifications.
5. Promote organization’s growth and adherence to industry standards in regard to product assurance, research & development, validations, document and data controls, supplier management, statistical techniques, etc. This includes technical review and approval of individual scientific and engineering protocols and reports as well as the identification of next-generation Quality System methods and toolsets.
6. Oversee the Quality Assurance function with the responsibility to ensure compliance within the context of business goals and objectives. Function includes, comprehensive audit program, complaint investigation, product recall, HACCP and document control.
7. Responsible for department budget and adherence to business plan, goals and objectives.
8. Provide responsive and consistent decisions to other business functions (e.g., Sales, Marketing, Operations, R&D) in support of their objectives.
9. Support new business development projects as needed (e.g., risk analyses for new products, agreements, due diligence, technology investigations).
10. Final approval for new products and testing criteria and customer analysis.
Marginal Functions:
Keep abreast of Food Industry and Regulatory trends and developments as it relates to our core business interests
Provide daily leadership and support for the QC and R&D department personnel