Senior Biologics Regulatory Quality Advisor

Kansas Ag Connection; Indianapolis (IN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Relocation packages

Parental leave (8 weeks)

Employee Resource Groups

Annual bonus

401(k) matching

Job summary

Elanco, a global leader in animal health, is seeking a Senior Quality Advisor for Biologics Regulatory Compliance to advance regulatory strategy and quality programs across the USDA CVB network.

You will partner with manufacturing, quality, regulatory and technical teams, represent the organization in interactions with USDA-CVB, and drive continuous improvement through data analysis, root cause solving, and technical writing.

Qualifications

• Bachelor's degree in a science discipline required; Master's/PhD preferred.
• Deep knowledge of biologics manufacturing and regulatory requirements (USDA 9 CFR, FDA, EU GMP).
• Experience leading cross-functional quality and regulatory initiatives.

Responsibilities

• Develop and execute strategic quality initiatives to strengthen regulatory compliance and quality performance.
• Serve as Alternate Liaison with USDA-CVB and manage regulatory submissions.
• Collaborate with Manufacturing, Sterility Assurance, Global Technical Services and others to resolve quality and compliance challenges across the biologics network.
• Support commercialization of new biologics through technology transfer and manufacturability reviews.
• Drive data analysis, benchmarking, and continuous improvement to improve compliance and operations.
• Coach teams on Root Cause Problem Solving, regulatory expectations, and technical writing.

Skills

Regulatory Compliance

Biologics Knowledge

Cross-functional Leadership

Education

Bachelor's in Biochemistry/ Biology/ Chemistry

Master's or PhD preferred

Job description

Elanco, a global leader in animal health, is seeking a Senior Quality Advisor for Biologics Regulatory Compliance to advance regulatory strategy and quality programs across the USDA CVB network.

You will partner with manufacturing, quality, regulatory and technical teams, represent the organization in interactions with USDA-CVB, and drive continuous improvement through data analysis, root cause solving, and technical writing.