As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
This role provides quality oversight and consultative support for animal health research and development activities. Partners with the business to meet the requirements of both Elanco and applicable regulatory authorities in support of global animal registrations. This role proactively drives compliance through implementation and monitoring of Elanco Quality Standards, training, and compliance tools. Partners with other Elanco Quality Organizations to assure GxP compliance is achieved.
Functions, Duties, Tasks:
- Responsible for planning and conducting oversight/audit activities for veterinary Good Clinical Practices (GCP according to VICH GL9) and/or pivotal Good Research Practices (according to internal GCP requirements) studies. Activities include independent planning and execution of protocol reviews and/or oversight of work completed at third parties. Issues QA statement for clinical study audits.
- Responsible for providing Sponsor oversight/audit activities for Good Laboratory Practice (GLP) studies completed at third parties: study protocol reviews and data/reports reviews.
- Issues inspection reports and reviews and approves responses and corrective actions for study audits. Independently follows up on audit responses and assesses the appropriateness of responses.
- Plan and execute process audits (self-inspections) of R&D internal processes (e.g., archive, data management processes, monitoring process, quality system driven activities, etc.).
- Builds and maintains relationships with business partners internal and external to R&D Quality and/or key Innovation/R&D business areas.
- Independently and appropriately escalates issues to Elanco quality and/or R&D management.
- Responsible for providing quality oversight and compliance consultation to the R&D organization.
- Bachelor’s Degree (minimum) in Science, Animal Science, or a related field; or equivalent experience.
- Demonstrates extensive knowledge in providing quality oversight or monitoring veterinary clinical studies completed in support of biologicals and/or pharmaceuticals submissions including those regulated by the USDA-CVM, FDA-CVM and/or EMA (5+ years ‘experience)
- Demonstrated working experience to veterinary Good Clinical Practices (GCP) requirements (VICH GL9) for animal health products.
- Location: Greenfield, IN (Open to relocation)
- Travel: 20%
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status