R&D Quality Auditor (m/f/d)
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What you'll do
- 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 they're looking for
- 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.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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 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)
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.
Company
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