R&D Quality Auditor (m/f/d)

Degree in Science (MSc, B.Pharm/M.Pharm, Postgraduate in Vet Sciences, or equivalent).

A minimum of 5 years of experience in auditing in animal health studies.

Demonstrated extensive experience in providing Quality Assurance oversight or Monitoring of veterinary clinical studies in support of regulatory submissions.

Knowledge in at least one of the following: GCP (VICH GL9) or OECD GLP.

Fluency in English (written and oral).

Good German or another EU language such as Spanish or Portuguese skills.

Ability to make decisions when there is no clear right or wrong answer.

Experience in the creation and/or revision of relevant Quality procedures and driving the rollout of quality processes for a site.

Provide Quality oversight to all functions within R&D and for assigned global projects, developing strong partnerships with stakeholders to proactively offer quality input and assist with risk assessments.

Plan and conduct GxP oversight activities, including GRP (Good Research Practice), GCP (Good Clinical Practice), or GLP (Good Laboratory Practice) study protocol, in-life, and data/reports reviews/audits, as well as site process self-inspections.

Review local and global procedures (Standard Operating Procedures - SOPs and Elanco Functional Procedures - EFPs) to ensure compliance with Elanco Quality Standards and Policies and relevant regulatory requirements.

Provide quality and compliance training to R&D personnel, developing training presentations on GxP or compliance topics as needed.

Maintain Quality Agreements with third parties for development activities and support Elanco Global Quality Compliance and Auditing (EGQCA) audits at third-party organizations.