Global Director, Biologics Quality & Compliance

Elanco; Kansas City (KS); Hybrid; USD 170,000 - 250,000; Full time

Benefits offered by this job

Hybrid work environment

Job summary

Elanco in the United States seeks an Executive Director, Quality for the Global Biologics Network. You will provide strategic leadership, define global quality strategy, and ensure cGMP compliance across biologics sites, including USDA standards.

You will lead inspection readiness, establish KPIs, drive continuous improvement, and collaborate with Manufacturing, Technical Services, and Supply Chain leadership to ensure product supply continuity. Travel up to 40%.

Qualifications

• Bachelor’s degree in a scientific or engineering field (e.g., chemistry, microbiology, pharmacy, or physical or biological sciences).
• Advanced degree (Masters or PhD) in Life Sciences, Management, or another relevant field preferred.
• 15+ years of experience in Quality Assurance/Operations in pharma/biotech, with 10+ years in senior leadership.

Responsibilities

• Direct the global quality strategy and risk management framework for the Biologics Manufacturing network to meet cGMP and USDA standards.
• Lead health authority inspection readiness programs across biologics sites and coordinate with Compliance teams.
• Establish and govern global quality KPIs and deploy Quality Risk Management methodologies for continuous improvement.
• Champion a global culture of quality with talent development, succession planning, and sharing best practices (LEAN).
• Ensure effective communication and escalation for critical quality issues, aligning global quality with site operations.

Skills

Quality leadership

GMP compliance

Risk management

Stakeholder management

Lean / process improvement

Quality metrics

Education

Bachelor's degree (science)

Advanced degree (Masters/PhD)

Job description

Elanco in the United States seeks an Executive Director, Quality for the Global Biologics Network. You will provide strategic leadership, define global quality strategy, and ensure cGMP compliance across biologics sites, including USDA standards.

You will lead inspection readiness, establish KPIs, drive continuous improvement, and collaborate with Manufacturing, Technical Services, and Supply Chain leadership to ensure product supply continuity. Travel up to 40%.