R&D Quality Auditor (m/f/d) in Monheim am Rhein

As an R&D Quality Auditor (m/f/d), you will provide essential quality and consultative support and oversight for animal health development activities supporting global projects. You will partner closely with Elanco R&D teams to drive compliance by implementing and monitoring Elanco Quality Standards, training, and compliance tools, ensuring GxP (Good Practice) adherence. **Your Responsibilities** - 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. **What You Need to Succeed (minimum qualifications)** - 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. **Your Benefits** - Employer subsidised pension scheme - 40 hours / week - 30 days holiday + opportunity to earn more time off - Active BGM and health care - Subsidy for the Deutschlandticket and bicycle leasing - Meal allowance in the canteens - Scope for personal initiative and opportunities for individual further training - Work in a dynamic team in an international company Additional Information: Travel within Europe: 40-60%, Location: Monheim (Germany)