Qualified Person

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: Qualified Person

As Qualified Person, you will oversee the technical review and certification of veterinary medicinal product batches released for the European market. Based in Elanco’s Dublin office, you will also manage the quality system for the Elanco Ireland Marketing Authorisation Holder and Importer entity, ensuring compliance with applicable pharmaceutical regulations, European Union Good Manufacturing Practice and Good Distribution Practice requirements.

Your Responsibilities:

• •Conduct technical reviews and certify European finished-product batches in accordance with Regulation 2019/6, Regulation (EU) 2025/2091 and applicable EU Good Manufacturing Practice requirements, including Articles 39 and 40.
• •Manage quality documentation and act as the primary contact for the European Manufacturing and Quality organisation regarding European batch releases, service-quality indicators, deadlines and follow-up actions.
• •Assess critical deviations with relevant stakeholders and support recall decisions, including participation in management notification processes and product-related governance meetings.
• •Maintain and improve the Elanco Ireland quality system by preparing and approving procedures, work instructions, site master file content, Qualified Person declarations and other product-supporting quality documents.
• •Manage change controls, deviations and self-inspections for the Elanco Ireland entity, support audits and inspections, communicate potential market issues to authorities, and share knowledge of European Union pharmaceutical quality expectations across the organisation.

What You Need to Succeed (minimum qualifications):

• •Qualified Person status for veterinary medicinal products in accordance with Regulation 2019/6 and applicable veterinary Good Manufacturing Practice requirements.
• •A minimum Master’s degree in a relevant scientific discipline.
• •At least two years of experience in a Quality department within a pharmaceutical site, or equivalent.
• •Demonstrated knowledge of pharmaceutical regulations, Good Manufacturing Practice and Good Distribution Practice.
• •Working knowledge of Microsoft Office, Veeva and SAP.

What will give you a competitive edge (preferred qualifications):

• •Experience with veterinary medicinal products and European batch release activities.
• •Practical experience managing quality systems, including change controls, deviations and self-inspections.
• •Experience supporting regulatory authority inspections, audits or market issue notifications.
• •Experience preparing quality documentation such as procedures, work instructions, site master file content or Qualified Person declarations.
• •Experience working with cross-functional European quality organisations and communicating quality information in English.

Additional Information:

• •Location: Dublin, Ireland.
• •Work model: 100% onsite from the Dublin office.

Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

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