
Director of Regulatory Affairs
- Irving, TX
- Permanent
- Full-time
- Provides leadership to facility PCQIs in developing/managing CGMP and Food Safety Plans to be compliant with 21 CFR §507 subparts B and C
- Oversees hazard analyses development/management for all products intended for use in animal and pet food
- Promotes internal reviews of Food Safety Plans at plant locations and assistance to plant management with corrective actions
- Interprets new FDA regulations that may affect operations of the company and assist in developing compliance plans and procedures.
- Oversees management and organization of the library of written CGMP and Food Safety Plans
- Promotes maintenance and application of changing regulations, regulatory standards and protocols
- Ensures compliance with various domestic guidelines
- Communicates findings to appropriate team members or internal customers
- Oversees compliance training development/management for:
- Developing Darling's network of lead instructors
- Working with lead instructors to train PCQIs as needed
- Working with plant management and facility PCQIs in the use of written CGMP and Food Safety Plans
- Supporting regional FSQA managers in training plant management and PCQIs
- Assisting in updating in-house training modules used for training Qualified Individuals.
- Provides guidance with interpreting testing results for biological and chemical hazards and in the design of appropriate interventions
- Assists the Vice President when required to respond to government inspections
- Serves as a resource to facility management during and in response to FDA inspections for compliance to 21 CFR §507 and government inspections
- Assists with consultation with both internal and external legal counsel
- Oversees verification, investigation and correction of regulatory label violations
- Oversees tracking and reporting on all audits/inspections for Darling animal food and fertilizer facilities
- Supports the company's two central analytical laboratories as needed
- Provides technical support in areas of expertise as needed
- Supervises Quality & Regulatory Affairs compliance team members
- Other duties as assigned
- Ph.D. in food safety, microbiology, meat science, agriculture/food policy or related field OR MS degree with 7+ years of experience
- HACCP and/or Preventive Control Qualified Individual (PCQI) certification required
- Experience managing a team in regulatory compliance/food safety/quality assurance, or related responsibility
- Experience in managing HACCP, Food Safety, GMP, CGMP plans is desirable
- Education/experience in regulatory compliance programs
- Experience in animal feed analysis preferred
- Prior experience with animal byproducts is desirable
- Be highly organized
- Good communication skills both written and oral
- Work well with all levels of the corporation
- Demonstrated expertise in lab methods desired