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

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)