Quality Assurance Advisor - R&D

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R&D Quality Assurance Auditor  ####

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** 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: R&D Quality Assurance Auditor
** This role provides quality oversight and consultative support for Elanco's R&D Clinical Development organization, serving as the GLP Test Facility Quality Assurance Unit to ensure regulatory compliance for non-clinical safety studies. Based at the Fort Dodge site, the position oversees regulated activities including VICH GL9 standards to support global product approvals for veterinary medicines. By partnering closely with R&D stakeholders, the role proactively drives compliance through the implementation of Elanco Quality Standards, specialized training, and strategic quality input.

** Your Responsibilities:**
* ** Regulatory Execution & Leadership:
** Execute the site Quality Assurance program in strict compliance with FDA GLP (21 CFR Part 58) and vGCP (VICH GL9) standards, while serving as the ERDQA representative to the R&D Site Lead Team.
* ** Comprehensive Auditing:
** Plan and conduct end-to-end internal and third-party audits-including protocol, in-life, data, and final report reviews-to ensure total adherence to regulatory requirements and Elanco Quality Systems.
* ** Sponsor & System Oversight:
** Provide critical Sponsor oversight for non-clinical safety and clinical studies conducted at third parties, while maintaining quality standards for R&D GXP equipment, systems, and site procedures.
* ** Quality Management & CAPA:
** Manage the Quality Management System (QMS) by authoring site Quality procedures, leading investigations into deviations, and overseeing the implementation and suitability of Corrective and Preventive Actions (CAPA).
* ** Stakeholder Engagement & Training:
** Act as a primary liaison for regulatory authority inspections and external stakeholders, while developing and delivering compliance training to R&D and ERDQA teams to foster a culture of quality.

** What You Need to Succeed (minimum qualifications):**
* *
* Education:

** Bachelor's of Science Degree in biology, animal science, pharmacy, or a related field.
* *
* Experience:

** At least 10 years of experience in a quality oversight or monitoring role for veterinary clinical and safety studies (FDA, USDA, EPA regulated).
* *
* Skills:

** Deep knowledge of GLP/GCP regulations, proven ability to influence senior scientific leaders, and a strong understanding of risk management and…