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

Elanco Animal Health GmbH; Monheim am Rhein; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Benefits dieser Stelle

Pension scheme (employer subsidised)

40 hours / week

30 days holiday

Health care

Deutschlandticket subsidy

Bicycle leasing subsidy

Meal allowance

Training opportunities

International team

Zusammenfassung

Elanco Animal Health GmbH is seeking an experienced R&D Quality Auditor to provide essential quality oversight and consultative support for animal health development activities, partnering with R&D teams to ensure GxP adherence across global projects. The role requires a Science degree and at least 5 years of auditing experience in animal health studies, with knowledge of GCP or GLP.

Fluent English and German or another EU language are preferred.

Qualifikationen

• Degree in Science (MSc, B.Pharm/M.Pharm, Postgraduate in Vet Sciences, or equivalent).
• Minimum 5 years of auditing experience in animal health studies.
• Extensive QA oversight or monitoring of veterinary clinical studies for regulatory submissions.
• Knowledge in GCP (VICH GL9) or OECD GLP.
• Fluency in English (written and oral).
• Good German or another EU language such as Spanish or Portuguese.
• Ability to make decisions when there is no clear right or wrong answer.
• Experience creating or revising Quality procedures and driving rollout of quality processes.

Aufgaben

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

Kenntnisse

Quality Assurance

Auditing

GxP knowledge

English fluency

German language

Risk assessment

Stakeholder management

Training delivery

Ausbildung

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

Jobbeschreibung

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)