Executive Director, Quality

Your Role: Executive Director, Quality - Global Biologics Network

Responsibilities:

• Provide strategic leadership and oversight for Elanco's Global Biologics Manufacturing Network, defining and executing the global quality strategy, mitigating risks, and ensuring robust quality performance across internal biologics manufacturing sites.
• Direct the global quality strategy, risk management framework, and product life cycle management for the Biologics Manufacturing network, aligned with international cGMP and USDA standards.
• Lead Health Authority inspection readiness programs across all biologics sites and partner with Compliance teams to implement standards across internal and external manufacturing networks.
• Establish and govern global quality performance metrics (KPIs) and deploy Quality Risk Management methodologies for continuous improvement, operational excellence, and audit readiness.
• Champion a global quality culture through talent development, succession planning, and best practices (e.g., LEAN).
• Serve as the ultimate point of escalation for critical quality issues and ensure alignment between global quality and site operations.

Minimum Qualifications:

• Bachelor's Degree in a scientific or engineering field.
• 15+ years in Quality Assurance/Operations in pharmaceutical/biotechnology; 10+ years in a senior leadership role.
• Deep expertise in biologics/vaccines manufacturing; knowledge of global cGMP standards (FDA, EMA, USDA) and leading international health authority inspections.
• Proven success guiding and developing high-performing quality teams globally.

Preferred Qualifications:

• Masters or PhD in Life Sciences, Management, or relevant field.
• Multi-site global quality management experience in Biologics/Vaccines (international experience valued).
• Ability to influence executive stakeholders in complex matrixed environments.
• Digital quality transformation experience and advanced data analytics for quality oversight.

Additional Information:

• Travel: 40%
• Location: Indianapolis, IN or Kansas City, MO (Hybrid)