Senior Biologics Quality & Regulatory Lead

Elanco in; Elwood (KS); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Employee resource groups

Annual bonus

401(k) matching

Job summary

Elanco is seeking a Senior Quality Advisor – Biologics Regulatory Compliance to lead regulatory and quality initiatives across the CVB network. This role partners with manufacturing sites and global quality teams to strengthen compliance, support innovation, and drive continuous improvement.

Location options include Elwood, KS; Indianapolis, IN; Fort Dodge, IA. Travel 15–25% is expected as you engage with site leaders and regulatory agencies to advance submissions and licensure.

Qualifications

• Bachelor's degree in Biochemistry, Chemistry, Biology, Virology or related science; Master's/PhD preferred.
• 10+ years in vaccine/biologics industry with increasing responsibility in Quality, Manufacturing or Regulatory Compliance.
• Deep knowledge of regulatory requirements (USDA 9 CFR, FDA, EU GMP).

Responsibilities

• Develop and execute strategic quality initiatives to strengthen regulatory compliance.
• Alternate Liaison for USDA Establishment; manage regulatory submissions and technical compliance discussions.
• Collaborate with Manufacturing, Sterility Assurance, Global Technical Services and other teams to resolve quality and compliance challenges.
• Support commercialization of new biologic products through cross-functional project teams and tech transfer oversight.
• Identify opportunities to improve compliance and operational performance through benchmarking and data analysis.

Skills

Biologics manufacturing

Regulatory compliance

Cross-functional leadership

Education

Bachelor's degree in Biochemistry/ Biology/ Virology

Job description

Elanco is seeking a Senior Quality Advisor – Biologics Regulatory Compliance to lead regulatory and quality initiatives across the CVB network. This role partners with manufacturing sites and global quality teams to strengthen compliance, support innovation, and drive continuous improvement.

Location options include Elwood, KS; Indianapolis, IN; Fort Dodge, IA. Travel 15–25% is expected as you engage with site leaders and regulatory agencies to advance submissions and licensure.