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:
- Bachelorβs 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).