Senior QA Advisor: Batch Release & Compliance

Elanco in; Fort Dodge (IA); On-site; USD 140,000 - 171,000; Full time

Job summary

Elanco is hiring a QA Advisor for Batch Release & Quality Oversight at the Fort Dodge site. You will ensure regulatory compliance, provide quality oversight across manufacturing operations, and authorize final product release to the U.S.

market while driving continuous improvement and inspection readiness. The role requires a Bachelor's degree in a scientific discipline and 10+ years in a regulated pharmaceutical/biologics environment, with deep cGMP/GLP knowledge and strong cross-functional

Qualifications

• Bachelor's degree in biology, chemistry, biochemistry, biopharmaceuticals, engineering, or related scientific discipline.
• Minimum of 10 years of experience in a regulated pharmaceutical, biologics, or vaccine manufacturing environment.
• Deep knowledge of cGMP/GLP regulations and quality systems combined with strong cross-functional leadership and decision‑making skills.

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.

Skills

cGMP/GLP knowledge

Cross-functional leadership

Education

Bachelor's degree in biology, chemistry, biochemistry, biopharmaceuticals, engineering, or related scientific discipline

Job description

Elanco is hiring a QA Advisor for Batch Release & Quality Oversight at the Fort Dodge site. You will ensure regulatory compliance, provide quality oversight across manufacturing operations, and authorize final product release to the U.S.

market while driving continuous improvement and inspection readiness. The role requires a Bachelor's degree in a scientific discipline and 10+ years in a regulated pharmaceutical/biologics environment, with deep cGMP/GLP knowledge and strong cross-functional