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.