Global Quality Director, Biologics & Projects

Elanco in; Indianapolis (IN); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Elanco is seeking an Executive Director of Quality to provide strategic leadership for the Global Biologics Manufacturing Network, ensuring robust quality performance, cGMP compliance, and readiness for health authority inspections. This role collaborates with Global Manufacturing, Technical Services, and Supply Chain to align quality with business growth.

The candidate will drive a culture of quality, develop leadership across sites, and manage risk across a multi-site network in a global

Qualifications

• Bachelor's degree in a scientific or engineering field.
• Minimum 15 years of experience in Quality Assurance/Operations in pharma/biotech.
• At least 10 years in a senior leadership role.
• Deep expertise in biologics and vaccines manufacturing; strong cGMP knowledge.

Responsibilities

• Define and execute global quality strategy for Biologics Manufacturing network.
• Lead health authority inspection readiness programs across biologics sites.
• Establish global quality KPIs and drive continuous improvement.
• Develop talent and succession planning within global quality teams.
• Ensure alignment between global quality and site operations.

Skills

Quality leadership

Regulatory compliance

Risk management

Stakeholder management

Global operations

Education

Bachelor's degree in science/engineering

Tools

Quality Management Systems (QMS)

cGMP knowledge

FDA/EMA/USDA standards

Job description

Elanco is seeking an Executive Director of Quality to provide strategic leadership for the Global Biologics Manufacturing Network, ensuring robust quality performance, cGMP compliance, and readiness for health authority inspections. This role collaborates with Global Manufacturing, Technical Services, and Supply Chain to align quality with business growth.

The candidate will drive a culture of quality, develop leadership across sites, and manage risk across a multi-site network in a global