Advisor, Quality Assurance

QA Advisor – Batch Release & Quality Oversight

Responsibilities:
- Provide quality oversight to ensure manufacturing, sampling, and testing activities comply with regulatory requirements, approved production outlines, 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 cross-functional teams.
- Support internal, corporate, and regulatory inspections, ensuring audit readiness, effective responses, and timely corrective actions.
- Review and approve quality investigations, stability reports, validation protocols, SOPs, and risk assessments while championing continuous improvement.

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

Preferred qualifications:
- Advanced degree (M.S., Ph.D., or equivalent).
- Experience with USDA biologics regulations, vaccine batch release, and product submission processes.
- Experience reviewing/approving deviations, investigations, CAPAs, validation documentation, and stability reports.
- Ability to lead quality initiatives and drive continuous improvement.
- Strong technical writing, communication, and stakeholder management skills.