Director

• Provide Subject Mater Expertise to ensure our company’s manufacturing sites adhere to compliance standards established in 9CFR and enforced by USDA-APHIS-CVB Inspection and Compliance (IC), and Policy, Licensing and Evaluation (PEL).
• Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements for facility design, auditing, quality systems and ensure team and company adherence to these documents.
• Develop a risk-based approach to prioritize USDA compliance requirements for our manufacturing sites.
• Understand and provide guidance on Ingredients of Animal Origin issues.
• Ensure any audits or sites assessments are conducted to assess compliance with applicable USDA regulations/ guidelines, customer requirements, SOPs and project specific guidelines/ instructions.
• Evaluate audit findings and ensure timely identification/ escalation of potential critical observations and compliance gaps observed during audits.
• Develop and maintain a strong training program for USDA requirements to increase knowledge and skills development and ability to detect and communicate GxP compliance concerns.
• Maintain up-to-date knowledge base with respect to emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements.
• Participate in industry groups (e.g. Animal Health Institute) that assess and influence standards and trends within Animal Health.
• Provide updates to company stakeholders on GxP and regulatory trends as well as the auditing program’s ability to detect compliance to current and evolving expectations.
• Ensure timely identification and escalation of potential critical observations and compliance gaps
• Assist during USDA audits.
• Oversee quality and compliance activities within assigned area of focus.
• Comply with all of our company's corporate guidelines and policies.

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