R&D Quality Assurance Auditor | GLP/GCP Compliance

Elanco; Fort Dodge (IA); On-site; USD 110,000 - 140,000; Full time

Job summary

Elanco is seeking an experienced R&D Quality Assurance Auditor for the Fort Dodge, Iowa site. The role ensures regulatory compliance for non-clinical safety studies and supports the GLP Test Facility QA unit.

Responsibilities include conducting audits, overseeing sponsor activities, maintaining the QMS, and delivering regulatory training to R&D teams to foster a culture of quality.

Qualifications

• Bachelor's degree in biology, animal science, pharmacy, or related field.
• At least 10 years in quality oversight for veterinary studies (FDA/USDA/EPA regulated).
• Deep knowledge of GLP/GCP regulations and risk management.

Responsibilities

• Regulatory execution & leadership: ensure GLP/GCP compliance and represent ERDQA on site leadership.
• Comprehensive auditing: plan and conduct internal and third-party audits across protocols and reports.
• Sponsor & system oversight: oversee non-clinical safety studies and site systems, ensure quality.
• Quality management & CAPA: maintain QMS, investigate deviations, implement CAPAs.
• Stakeholder engagement & training: liaise with regulators and train R&D teams on compliance.

Skills

GLP/GCP knowledge

Influence senior leaders

Risk management

Quality systems

Education

BS in biology/animal science/pharmacy

Master's in Life Sciences

DVM (optional)

Job description

Elanco is seeking an experienced R&D Quality Assurance Auditor for the Fort Dodge, Iowa site. The role ensures regulatory compliance for non-clinical safety studies and supports the GLP Test Facility QA unit.

Responsibilities include conducting audits, overseeing sponsor activities, maintaining the QMS, and delivering regulatory training to R&D teams to foster a culture of quality.