Executive Director, Quality
Elanco
August 14, 2026
Remote friendly (Indianapolis, IN)
United States
Operations
Your Role: Executive Director, Quality - Global Biologics Network
Responsibilities:
- Direct the global quality strategy, risk management framework, and product life cycle management for the Biologics Manufacturing network, ensuring alignment with international cGMP and USDA standards.
- Lead Health Authority inspection readiness programs across all biologics sites and partner with Compliance teams to drive implementation of standards across internal and external manufacturing networks.
- Establish and govern global quality performance metrics (KPIs) and deploy Quality Risk Management methodologies to drive continuous improvement, operational excellence, and audit readiness.
- Champion a global culture of quality through talent development, succession planning, and sharing 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 (e.g., chemistry, microbiology, pharmacy, or physical/biological sciences).
- 15+ years in Quality Assurance/Operations in pharmaceutical/biotechnology; 10+ years in a senior leadership role.
- Deep expertise in biologics and vaccines manufacturing processes; working knowledge of global cGMP standards (FDA, EMA, USDA); proven record leading international health authority inspections.
- Demonstrated success guiding and developing high-performing quality teams globally.
Preferred Qualifications:
- Masters or PhD in Life Sciences, Management, or relevant field.
- Experience managing quality across a multi-site global biologics/vaccines network (international experience valued).
- Ability to influence executive stakeholders in complex, matrixed environments.
- Experience with digital quality transformation and use of advanced data analytics for quality oversight.
Additional Information:
- Travel: 40%
- Location: Indianapolis, IN or Kansas City, MO — Hybrid Work Environment
Responsibilities:
- Direct the global quality strategy, risk management framework, and product life cycle management for the Biologics Manufacturing network, ensuring alignment with international cGMP and USDA standards.
- Lead Health Authority inspection readiness programs across all biologics sites and partner with Compliance teams to drive implementation of standards across internal and external manufacturing networks.
- Establish and govern global quality performance metrics (KPIs) and deploy Quality Risk Management methodologies to drive continuous improvement, operational excellence, and audit readiness.
- Champion a global culture of quality through talent development, succession planning, and sharing 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 (e.g., chemistry, microbiology, pharmacy, or physical/biological sciences).
- 15+ years in Quality Assurance/Operations in pharmaceutical/biotechnology; 10+ years in a senior leadership role.
- Deep expertise in biologics and vaccines manufacturing processes; working knowledge of global cGMP standards (FDA, EMA, USDA); proven record leading international health authority inspections.
- Demonstrated success guiding and developing high-performing quality teams globally.
Preferred Qualifications:
- Masters or PhD in Life Sciences, Management, or relevant field.
- Experience managing quality across a multi-site global biologics/vaccines network (international experience valued).
- Ability to influence executive stakeholders in complex, matrixed environments.
- Experience with digital quality transformation and use of advanced data analytics for quality oversight.
Additional Information:
- Travel: 40%
- Location: Indianapolis, IN or Kansas City, MO — Hybrid Work Environment