Advisor-Quality Assurance

elanco; Iowa City (IA); Vor Ort; USD 110.000 - 170.000; Vollzeit

Zusammenfassung

Elanco is seeking an experienced R&D Quality Assurance Auditor to provide quality oversight for the Clinical Development organization at the Fort Dodge site. You will serve as the GLP Test Facility QA unit, ensuring regulatory compliance for non-clinical safety studies and partnering with R&D stakeholders to drive quality improvements.

Responsibilities include leading audits (protocol, in-life, data and final reports), sponsor and system oversight for non-clinical safety and clinical studies,

Qualifikationen

• Bachelor's degree in biology, animal science, pharmacy, or related field.
• At least 10 years of quality oversight for veterinary clinical/safety studies.
• Strong knowledge of GLP/GCP regulations and quality systems.

Aufgaben

• Execute the site QA program in compliance with FDA GLP and vGCP standards as ERDQA representative.
• Plan and conduct end-to-end internal and third‑party audits across protocols and reports.
• Provide sponsor oversight for non‑clinical safety studies and_manage site QMS and CAPA.
• Lead investigations into deviations and deliver regulatory training to R&D/ERDQA teams.
• Serve as primary liaison for regulatory inspections and external stakeholders.

Kenntnisse

GLP/GCP

Stakeholder influence

Risk management

Quality Systems

10+ years QA experience

Ausbildung

Bachelor's of Science Degree

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 – join our team today!

Your Role: R&D Quality Assurance Auditor

This role provides quality oversight and consultative support for Elanco’s R&D Clinical Development organization, serving as the GLP Test Facility Quality Assurance Unit to ensure regulatory compliance for non-clinical safety studies. Based at the Fort Dodge site, the position oversees regulated activities including VICH GL9 standards to support global product approvals for veterinary medicines. By partnering closely with R&D stakeholders, the role proactively drives compliance through the implementation of Elanco Quality Standards, specialized training, and strategic quality input.

Your Responsibilities:

• Regulatory Execution & Leadership: Execute the site Quality Assurance program in strict compliance with FDA GLP (21 CFR Part 58) and vGCP (VICH GL9) standards, while serving as the ERDQA representative to the R&D Site Lead Team.
• Comprehensive Auditing: Plan and conduct end-to-end internal and third-party audits—including protocol, in-life, data, and final report reviews to ensure total adherence to regulatory requirements and Elanco Quality Systems.
• Sponsor & System Oversight: Provide critical Sponsor oversight for non-clinical safety and clinical studies conducted at third parties, while maintaining quality standards for R&D GXP equipment, systems, and site procedures.
• Quality Management & CAPA: Manage the Quality Management System (QMS) by authoring site Quality procedures, leading investigations into deviations, and overseeing the implementation and suitability of Corrective and Preventive Actions (CAPA).
• Stakeholder Engagement & Training: Act as a primary liaison for regulatory authority inspections and external stakeholders, while developing and delivering compliance training to R&D and ERDQA teams to foster a culture of quality.

What You Need to Succeed (minimum qualifications):

• Education: Bachelor's of Science Degree in biology, animal science, pharmacy, or a related field.
• Experience: At least 10 years of experience in a quality oversight or monitoring role for veterinary clinical and safety studies (FDA, USDA, EPA regulated).
• Skills: Deep knowledge of GLP/GCP regulations, proven ability to influence senior scientific leaders, and a strong understanding of risk management and Quality Systems.

What Will Give You the Competitive Edge (preferred qualifications):

• Master’s in Life Sciences or a Doctor of Veterinary Medicine.
• Society for Quality Assurance RQAP-GLP certification.
• Experience with IACUC, Biosafety Committees, and Health and Safety protocols.

Additional Information:

• Location: Fort Dodge, Iowa (On-site Position)

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.