Quality Assurance Auditor (GCP/GLP)

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.

We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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 Auditor (GCP/GLP)

As a Quality Assurance Auditor (GCP/GLP), you will play a pivotal role in advancing animal health innovation by leading quality oversight and providing consultative support for research and development initiatives.

Your commitment to excellence in GxP compliance will ensure adherence to Elanco and regulatory standards globally.

Your Responsibilities:


* Plan and have oversight of clinical audit activities for veterinary Good Clinical Practices (GCP) and/or pivotal Good Research Practices studies, ensuring compliance with internal and external standards.


* Provide Sponsor oversight/audit activities for Good Laboratory Practice (GLP) studies completed at third parties, including protocol reviews and data/reports reviews.


* Issue inspection reports, review and approve responses, and assess the appropriateness of corrective actions for study audits.


* Plan and execute process audits (self-inspections) of R&D internal processes, such as archive and data management processes, to ensure quality system-driven activities.


* Build and maintain relationships with internal and external business partners, escalating issues to Elanco quality and/or R&D management as needed.

What You Need to Succeed (minimum qualifications):


* Education: Bachelor’s Degree in Science, Animal Science, or a related field; RQAP-GLP certification desired.


* Experience: Experience in the pharmaceutical industry (preferably veterinary) with understanding of veterinary clinical studies and regulatory requirements (e.g., GCP, GLP).


* Strong facilitation and project management skills and an analytical mindset with systematic process-oriented thinking.

What will give you a competitive edge (preferred qualifications):


* Experience in quality management system activities.


* Knowledge and experience in clinical study and/or supplier audits.

Additional Information:


* Travel: 20% across the U.S.


* Location: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment

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