Global Quality Executive - Biologics (Remote/Travel)

Elanco US; United States; Remote; USD 182,000 - 273,000; Full time

Benefits offered by this job

Company bonus

401(k) matching

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Prescription drug benefits

Flexible benefits

Job summary

Elanco is seeking an Executive Director of Quality - Global Biologics Network to provide strategic leadership for the worldwide biologics manufacturing quality program. You will define and execute the global quality strategy, mitigate risks, and ensure robust quality performance across internal biologics manufacturing sites in accordance with cGMP and USDA standards.

You will lead health authority inspection readiness, establish KPIs, and drive continuous improvement while aligning quality

Qualifications

• Bachelor's Degree in a scientific or engineering field.
• Minimum 15 years of experience in Quality Assurance/Operations within the pharmaceutical or biotechnology industry, with at least 10 years in a senior leadership role.
• Deep expertise in biologics and vaccines manufacturing processes, global cGMP standards (FDA, EMA, USDA), and proven track record of leading international health authority inspections.
• Leadership experience guiding and developing high-performing quality teams in a global environment.

Responsibilities

• Lead the global quality strategy, risk management framework, and product life cycle management for the Biologics Manufacturing network.
• Oversee Health Authority inspection readiness programs across all biologics sites and drive standards across networks.
• Establish and govern global quality performance metrics (KPIs) and deploy Quality Risk Management methodologies.
• Champion a global culture of quality, talent development, succession planning, and lean productivity improvements.
• Ensure effective communication and escalation for critical quality issues, aligning global quality with site operations.

Skills

Quality Assurance

Operations leadership

Global quality strategy

Regulatory inspections

Cross-functional collaboration

Education

Bachelor's Degree in a scientific or engineering field

Job description

Elanco is seeking an Executive Director of Quality - Global Biologics Network to provide strategic leadership for the worldwide biologics manufacturing quality program. You will define and execute the global quality strategy, mitigate risks, and ensure robust quality performance across internal biologics manufacturing sites in accordance with cGMP and USDA standards.

You will lead health authority inspection readiness, establish KPIs, and drive continuous improvement while aligning quality