Advisor, Quality Assurance - 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 (m/w/d) - Fokus Vaccine Manufacturing Compliance
The Qualified Person will be responsible for the release of high-quality vaccines and act as a strategic anchor for manufacturing compliance. In this key function, this person will ensure our production processes always meet the highest quality standards and regulatory requirements.
Your Responsibilities:
Batch Release: Independently certify and release veterinary vaccines for national and international markets while maintaining the official release register.
Manufacturing Compliance & Monitoring: Partner with production to monitor and optimize processes, ensuring all manufacturing steps follow validated conditions and GMP documentation standards.
Quality Systems Management: Evaluate production-related deviations, CAPAs, and change control procedures to ensure consistent quality and compliance.
Audit & Inspection Readiness: Lead the preparation and support for official regulatory inspections as well as external customer audits.
GMP Technical Advisory: Serve as a key organizational interface, advising specialist departments on all GMP-relevant issues relating to vaccine production.
What You Need to Succeed (minimum qualifications):
Qualification: Meeting the expert knowledge requirements for a Qualified Person (QP) in accordance with Article 97 of Regulation (EU) 2019/6 and Section 5 of the German Veterinary Vaccine Regulation (Tierimpfstoff-Verordnung)."
10+ years of professional experience in the pharmaceutical industry
Fluent in German and English, both written and spoken.
What will give you a competitive edge (preferred qualifications):
Experience with production of biological products or sterile dosage forms.
In-depth knowledge of national and international GMP regulations with a strong understanding of compliance structures in manufacturing.
Analytical thinking, decisiveness and the ability to communicate complex issues precisely.
Additional Information:
Location: Cuxhaven, Germany - On-site Work Environment
Travel: 10%
WHAT WE OFFER YOU
Performance-based and attractive compensation, including participation in company success
Employer contribution to pension plans
40-hour work week
30 days of annual leave
Meal allowance subsidy
Regular team events
Health and fitness programs as well as access to Corporate Benefits
Freedom for personal initiative and opportunities for individual professional development
Working in a dynamic team within an international company
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.