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

Elanco; United States; On-site; USD 75,000 - 109,000; Full time

Benefits offered by this job

Employer subsidised pension scheme

40 hours per week

30 days holiday + extra time off

Health care

Deutschlandticket subsidy

Bicycle leasing

Meal allowance

Opportunities for personal development

Work in an international team

Job summary

Elanco is seeking an experienced R&D Quality Auditor to provide quality oversight and consultation for animal health development activities. You will work with R&D teams to drive compliance with GxP standards, train personnel, and manage quality agreements with third parties while supporting audits across Europe.

The role requires at least 5 years in audit experience, a science degree, and fluency in English; German or another EU language is a plus.

Qualifications

• Degree in Science (MSc, B.Pharm/M.Pharm, or equivalent).
• At least 5 years auditing experience in animal health studies.
• Experience providing QA oversight in veterinary clinical studies for regulatory submissions.
• Knowledge in GCP (VICH GL9) or OECD GLP.
• Fluency in English; good German or another EU language.

Responsibilities

• Provide Quality oversight to R&D functions and global projects.
• Plan and conduct GxP oversight activities including GRP, GCP, or GLP studies.
• Review SOPs and EFPs for compliance with Elanco Quality Standards and regulatory requirements.
• Provide QA training to R&D personnel on GxP topics.
• Maintain Quality Agreements with third parties and support EGQCA audits.

Skills

Quality Assurance

GxP knowledge

Auditing experience

English fluency

German or EU language

Education

Science degree (MSc/B.Pharm/M.Pharm)

Job description

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. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

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: 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 bicycleleasing
• 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)

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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.