Executive Director, Quality

This is a fully remote position, open to applicants in Kansas.

📋 Description

• Provide strategic direction and oversight for Elanco's Global Biologics Manufacturing Network.

• Develop and implement the global quality strategy.

• Mitigate risks and guarantee strong quality performance across internal biologics manufacturing facilities.

• Maintain the integrity of the biologics supply chain and ensure compliance with global cGMP and evolving regulatory standards, including USDA requirements.

• Collaborate with executives from Global Manufacturing, Technical Services, and Supply Chain to synchronize quality goals with business growth and product supply continuity.

• Lead the global quality strategy, risk management framework, and product life cycle management for the Biologics Manufacturing network.

• Oversee Health Authority inspection readiness initiatives across all biologics sites.

• Partner with Compliance teams to establish standards throughout internal and external manufacturing networks.

• Set and govern global quality performance metrics and implement Quality Risk Management methodologies.

• Propel continuous improvement, operational excellence, and audit readiness.

• Foster a global culture of quality through talent development, succession planning, and the sharing of best practices in productivity and operational enhancements, including LEAN.

• Act as the primary escalation point for critical quality issues and ensure alignment between global quality and site operations.

⛳️ Requirements

• Bachelor's Degree in a scientific or engineering discipline (e.g., chemistry, microbiology, pharmacy, or physical or biological sciences).

• A minimum of 15 years of experience in Quality Assurance/Operations within the pharmaceutical or biotechnology sectors.

• At least 10 years in a senior leadership capacity.

• Extensive knowledge of biologics and vaccine manufacturing processes.

• In-depth understanding of global cGMP standards (FDA, EMA, USDA).

• Proven history of leading international health authority inspections.

• Demonstrated success in guiding and developing high-performing quality teams in a global context.

• Advanced degree (Masters or PhD) in Life Sciences, Management, or a related scientific field is preferred.

• Experience managing quality across a multi-site global network in the Biologics and Vaccines domains, with international experience highly regarded is preferred.

• Strong ability to influence executive stakeholders and navigate complex, matrixed global settings is preferred.

• Proven experience in digital quality transformation and utilizing advanced data analytics for quality oversight is preferred.

• Willingness to travel 40% of the time.

🏝️ Benefits

• Company bonus eligibility for full-time equivalent employees.

• Company-matching 401(k) plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.