Biologics QA & Regulatory Compliance Lead

Elanco; Fort Dodge (IA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Relocation packages

8-week parental leave

9 Employee Resource Groups

Annual bonus opportunity

Up to 6% 401(k) matching

Job summary

Elanco in the United States seeks a Senior Quality Advisor for Biologics Regulatory Compliance to lead strategic quality initiatives and strengthen regulatory compliance across the biologics network.

The role requires deep regulatory knowledge (USDA/FDA/EU GMP), cross-functional collaboration, and hands-on guidance in biologics manufacturing and technology transfer, with ~15–25% travel and relocation options.

Qualifications

• Bachelor's degree in biochemistry, chemistry, biology, virology or related science required; Master's/PhD preferred.
• Minimum 10 years in vaccine, biologics or biotech with increasing responsibility in quality, manufacturing, or regulatory compliance.
• Deep knowledge of biologics manufacturing and regulatory requirements (USDA 9 CFR, FDA, and EU GMP).

Responsibilities

• Develop and execute strategic quality initiatives to strengthen regulatory compliance and improve quality performance across the biologics network.
• Serve as Alternate Liaison for USDA Establishment, managing regulatory submissions and technical compliance discussions.
• Partner with Manufacturing, Sterility Assurance, Global Technical Services, Central Quality and cross-functional teams to resolve quality and compliance challenges.

Skills

Biologics manufacturing

Regulatory knowledge

Cross-functional leadership

Stakeholder influence

Education

Bachelor's degree in sciences

Advanced degree preferred

Job description

Elanco in the United States seeks a Senior Quality Advisor for Biologics Regulatory Compliance to lead strategic quality initiatives and strengthen regulatory compliance across the biologics network.

The role requires deep regulatory knowledge (USDA/FDA/EU GMP), cross-functional collaboration, and hands-on guidance in biologics manufacturing and technology transfer, with ~15–25% travel and relocation options.