Advisor, Quality Assurance - Qualified Person

Elanco Tiergesundheit AG; Cuxhaven; Vor Ort; EUR 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Performance-based compensation

Pension contributions

40-hour work week

30 days annual leave

Meal allowance subsidy

Team events

Wellness programs

Corporate Benefits

Zusammenfassung

Elanco is seeking a Qualified Person (m/w/d) focused on vaccine manufacturing compliance at our Cuxhaven site in Germany. You will certify batch releases for national and international markets, ensuring GMP standards are met.

You will lead regulatory inspections, advise on GMP issues across vaccine production, and collaborate with production teams in a global animal health company. Fluency in German and English is required, with more than 10 years in the pharmaceutical field.

Qualifikationen

• Minimum 10+ years in the pharmaceutical industry.
• Expert knowledge of EU QP requirements and GMP.
• Fluent in German and English, written and spoken.

Aufgaben

• Batch release: certify and release veterinary vaccines for national and international markets.
• Monitor manufacturing processes to ensure GMP documentation standards.
• Evaluate deviations, CAPAs, and change controls for quality.
• Lead preparation and support for regulatory inspections and external audits.
• Advise departments on GMP-related issues in vaccine production.

Kenntnisse

QP knowledge

GMP Compliance

Regulatory affairs

Quality assurance

Analytical thinking

German language

English language

Ausbildung

Qualified Person certification

Jobbeschreibung

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 –

Your Role: Qualified Person (m/w/d) – Fokus Vaccine Manufacturing Compliance

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.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose CSR framework – all to advance the health of animals, people and the planet.