Advisor, Quality Assurance

Elanco Tiergesundheit AG; Fort Dodge (IA); On-site; USD 90,000 - 110,000; Full time

Job summary

Elanco Tiergesundheit AG is seeking a Quality Assurance Advisor in Fort Dodge, Iowa. This role involves ensuring regulatory compliance and quality oversight in vaccine manufacturing, with responsibilities including reviewing batch documentation and supporting inspections.

The ideal candidate will have a Bachelor's degree in a scientific discipline and at least 10 years of experience in a regulated environment. Strong knowledge of cGMP/GLP regulations and leadership skills are essential.

Qualifications

• 10+ years in a regulated pharmaceutical or vaccine manufacturing environment.
• Expertise in quality oversight and regulatory compliance.

Responsibilities

• Provide quality oversight for manufacturing and testing activities.
• Review and approve batch documentation and analytical data.
• Support internal and regulatory inspections and audit readiness.

Skills

Deep knowledge of cGMP/GLP regulations

Strong cross-functional leadership

Decision-making skills

Education

Bachelor's degree in biology, Chemistry, Biochemistry, Biopharmaceuticals, Engineering

Job description

## Advisor, Quality AssuranceApplylocations: Fort Dodge, IAtime type: Full timeposted on: Posted Todayjob requisition id: R0026236**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: QA Advisor – Batch Release & Quality Oversight**As the **QA** ****–** Batch Release & Quality Oversight**, you will be part of the Quality organization supporting vaccine manufacturing and product release activities at the Fort Dodge site. In this role, you will be responsible for ensuring regulatory compliance, providing quality oversight across manufacturing operations, and authorizing final product release to the U.S. market while driving continuous improvement and inspection readiness.### **Your Responsibilities:**• Provide quality oversight to ensure manufacturing, sampling, and testing activities comply with regulatory requirements, outlines of production, and Elanco quality standards. • Review and approve batch documentation, analytical data, deviations, change controls, and CAPAs to support final product release and submission to USDA for market authorization. • Serve as a Quality and GMP Subject Matter Expert (SME), providing technical guidance, training, and support across Manufacturing, Quality, and other cross-functional teams. • Support internal, corporate, and regulatory inspections, ensuring audit readiness, effective responses, and timely completion of corrective actions. • Review and approve quality investigations, stability reports, validation protocols, SOPs, and risk assessments while championing continuous improvement initiatives across the site and network.### **What You Need to Succeed (minimum qualifications):**• **Education:** Bachelor's degree in biology, Chemistry, Biochemistry, Biopharmaceuticals, Engineering, or related scientific discipline. • **Experience:** Minimum of 10 years of experience in a regulated pharmaceutical, biologics, or vaccine manufacturing environment. • **Top 2 skills:** Deep knowledge of cGMP/GLP regulations and quality systems combined with strong cross-functional leadership and decision-making skills.### **What Will Give You a Competitive Edge (preferred qualifications):**• Advanced degree (M.S., Ph.D., or equivalent) in a scientific or technical discipline. • Experience with USDA biologics regulations, vaccine batch release, and product submission processes. • Demonstrated experience reviewing and approving deviations, investigations, CAPAs, validation documentation, and stability reports. • Proven ability to lead quality initiatives and drive continuous improvement in a regulated manufacturing environment. • Strong technical writing, communication, and stakeholder management skills with the ability to influence across all organizational levels.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 statusElanco 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.