Executive Director, Quality

Scorpion Therapeutics; Kansas City (KS); Hybrid; USD 200,000 - 280,000; Full time

Job summary

Elanco is seeking an Executive Director of Quality for the Global Biologics Network. The role leads strategic quality direction across internal biologics sites, aligning with cGMP standards and global health authority expectations.

You will drive risk management, KPI deployment, and continuous improvement while fostering a global quality culture. The position requires extensive leadership experience in biologics manufacturing, a strong track record with regulatory inspections, and the ability to

Qualifications

• Bachelor's degree required 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 with global cGMP (FDA/EMA/USDA) knowledge.

Responsibilities

• Provide strategic leadership and oversight for the Global Biologics Manufacturing Network.
• Direct the global quality strategy and risk management for the network.
• Lead Health Authority inspection readiness and liaise with Compliance teams.

Skills

Quality Assurance

Operations Leadership

Biologics Manufacturing

cGMP Compliance

Health Authority Inspections

Data Analytics

Education

Bachelor's Degree in a scientific or engineering field

Master's or PhD in Life Sciences or related field

Job description

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)