Advisor, Quality Assurance

Your Role

QA Advisor – Batch Release & Quality Oversight

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.

Requirements

• 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.

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.

What Will Give You a Competitive Edge

• Deep knowledge of cGMP/GLP regulations and quality systems combined with strong cross-functional leadership and decision-making skills.

Elanco

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.