Global R&D Quality Auditor – GxP & Compliance

Elanco; United States; On-site; USD 75,000 - 109,000; Full time

Benefits offered by this job

Employer subsidised pension scheme

40 hours per week

30 days holiday + extra time off

Health care

Deutschlandticket subsidy

Bicycle leasing

Meal allowance

Opportunities for personal development

Work in an international team

Job summary

Elanco is seeking an experienced R&D Quality Auditor to provide quality oversight and consultation for animal health development activities. You will work with R&D teams to drive compliance with GxP standards, train personnel, and manage quality agreements with third parties while supporting audits across Europe.

The role requires at least 5 years in audit experience, a science degree, and fluency in English; German or another EU language is a plus.

Qualifications

• Degree in Science (MSc, B.Pharm/M.Pharm, or equivalent).
• At least 5 years auditing experience in animal health studies.
• Experience providing QA oversight in veterinary clinical studies for regulatory submissions.
• Knowledge in GCP (VICH GL9) or OECD GLP.
• Fluency in English; good German or another EU language.

Responsibilities

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

Skills

Quality Assurance

GxP knowledge

Auditing experience

English fluency

German or EU language

Education

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

Job description

Elanco is seeking an experienced R&D Quality Auditor to provide quality oversight and consultation for animal health development activities. You will work with R&D teams to drive compliance with GxP standards, train personnel, and manage quality agreements with third parties while supporting audits across Europe.

The role requires at least 5 years in audit experience, a science degree, and fluency in English; German or another EU language is a plus.