Quality Assurance Consultant - Supplier Management

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.
At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role:
Quality Assurance Consultant - Supplier Management

This critical role is responsible for establishing, implementing, and maintaining Elanco's Supplier, Service Provider, and Consultant Management Program. Leveraging a risk-based approach and adhering to Elanco Quality Standards, you will ensure the quality, compliance, and reliability of all outsourced materials and services, aligning with Elanco's commitment to excellence in animal health.

Your Responsibilities:

• Develop, implement, and manage Elanco's Supplier, Service Provider, and Consultant Management Program in accordance with Elanco Quality Standards. Collaborate with Procurement, R&D, Manufacturing, and other internal stakeholders to define quality requirements and specifications for materials and services, ensuring the involvement of the Quality Unit in all quality-related matters. Maintain accurate and current lists of approved Suppliers, Service Providers, and Consultants, ensuring all entities hold appropriate licenses.
  
  Oversee the Commercial Supplier certification program, including the assessment of low-risk materials and the process for downgrading or rejecting certified suppliers.
• Lead supplier qualification activities, including due diligence assessments (e.g., questionnaires, site visits, interviews), risk assessments (e.g., HACCP, FMEA), and evaluations of potential Suppliers, Service Providers, and Consultants based on predefined criteria. Conduct and oversee supplier audits in accordance with Elanco Quality Standards, ensuring compliance with applicable legal, regulatory, and marketing authorization requirements, including GXP.
• Apply Quality Risk Management principles throughout the entire lifecycle of supplier relationships, from Selection and Implementation to Operations and Termination. Ensure all lifecycle activities, including changes to a supplier's risk profile, are managed under change control in accordance with Elanco Quality Standards. Manage supplier Change Notification process, ensuring collaborative stakeholder review and initiation of change control as required.
• Ensure the establishment and approval of Quality Agreements with critical Suppliers and Service Providers, and ensuring clear expectations and responsibilities. Manage supplier non-conformance investigations, root cause analysis, and the implementation of effective Corrective and Preventive Actions (CAPA) in line with Elanco Quality Standards. Monitor and report on supplier performance metrics, conducting periodic reviews proportionate to risk, and driving continuous improvement initiatives.
• Participate in site audits and inspection readiness activities as needed. Participate in and manage QA projects with minimal supervision. Receive overall project direction from management but complete most work independently. Assist other Quality Assurance Associate(s) and Quality Management as needed.

What You Need to Succeed (minimum qualifications):

Education: Bachelor’s degree in scientific discipline (preferred), with 8 years Quality Assurance experience in a regulated

industry (USDA, FDA, ISO etc).

Experience:

• Strong knowledge of GMP (Good Manufacturing Practices) and ISO quality standards, with a solid understanding of GXP requirements.
• Proven experience in conducting supplier audits and managing CAPA processes, specifically within a…