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Elanco

Global animal health pharmaceutical company

Quality Assurance Consultant - Supplier Management

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeElwood, KS, USANo salary listed

About the Job

Requirements

  • Eight years of Quality Assurance experience in a regulated industry, such as USDA, FDA, or ISO-regulated environments.
  • Strong knowledge of Good Manufacturing Practices and ISO quality standards, with a solid understanding of GXP requirements.
  • Experience conducting supplier audits and managing Corrective and Preventive Action processes within a structured Quality Management System.
  • Experience applying Quality Risk Management principles and tools, such as HACCP and FMEA.
  • Familiarity with USDA regulatory standards.
  • Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion.
  • Must be legally authorized to be employed in the United States.

Responsibilities

  • Develop, implement, and manage the Supplier, Service Provider, and Consultant Management Program in accordance with company Quality Standards.
  • Collaborate with Procurement, R&D, Manufacturing, and internal stakeholders to define quality requirements and specifications for materials and services, ensuring Quality Unit involvement in quality-related matters.
  • Maintain current lists of approved Suppliers, Service Providers, and Consultants, ensuring each holds appropriate licenses.
  • Oversee the Commercial Supplier certification program, including assessing low-risk materials and downgrading or rejecting certified suppliers.
  • Lead supplier qualification activities, including due diligence assessments such as questionnaires, site visits, and interviews; risk assessments such as HACCP and FMEA; and evaluations based on predefined criteria.
  • Conduct and oversee supplier audits in accordance with company Quality Standards and applicable legal, regulatory, and marketing authorization requirements, including GXP.
  • Apply Quality Risk Management principles throughout supplier relationship lifecycles, from selection and implementation through operations and termination.
  • Ensure supplier lifecycle activities, including risk-profile changes, are managed under change control in accordance with company Quality Standards.
  • Manage the supplier Change Notification process, coordinating stakeholder review and initiating change control as required.
  • Establish and approve Quality Agreements with critical Suppliers and Service Providers, clarifying expectations and responsibilities.
  • Manage supplier non-conformance investigations, root-cause analysis, and effective Corrective and Preventive Actions in line with company Quality Standards.
  • Monitor and report supplier performance metrics, conduct periodic risk-proportionate reviews, and drive continuous improvement initiatives.
  • Participate in site audits and inspection-readiness activities as needed.
  • Participate in and manage Quality Assurance projects with minimal supervision, completing most work independently under overall project direction from management.
  • Assist other Quality Assurance Associates and Quality Management as needed.
  • Travel domestically and internationally as required, up to 25%.

Desired Qualifications

  • A bachelor's degree in a scientific discipline is preferred.
  • Excellent communication, negotiation, and interpersonal skills for collaboration with internal and external stakeholders.
  • Ability to work independently with minimal oversight.
  • Ability to work in controlled environments as needed.
  • Experience making sound independent decisions.
  • Ability to read, write, and converse in English.
  • Experience with electronic Quality Management Systems.
  • Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
  • Eagerness to learn and continuously improve, with a positive work attitude supporting teamwork and continuous improvement.

About the Company

Elanco

Global animal health pharmaceutical company

Elanco is a global animal health company that develops and sells medicines, vaccines, and preventive care products for livestock and pets. Its portfolio includes prescription medicines, vaccines, parasite controls, and other welfare products used by veterinarians, farmers, and pet owners to prevent or treat disease and improve wellbeing. Since becoming independent after separating from Eli Lilly and acquiring Bayer Animal Health in 2020, it ranks as the world’s second-largest animal health company with a broad, globally distributed product line and direct-to-consumer capabilities. Its goal is to improve animal health and welfare worldwide by providing effective, accessible products and services while growing sustainably.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Indianapolis, IN
Founded
1954

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