Executive Director, Quality

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

Executive Director, Quality (Project Management)

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals' lives better makes life better – join our team today!

Your Role: Executive Director, Quality - Global Biologics Network

As Executive Director, Quality, you will provide strategic leadership and oversight for Elanco's Global Biologics Manufacturing Network. You will be accountable for defining and executing the global quality strategy, mitigating risks, and ensuring robust quality performance across all internal biologics manufacturing sites. This role is pivotal in upholding the integrity of the biologics supply chain and assuring compliance with worldwide cGMP and evolving regulatory requirements, including USDA standards. You will be a key member of internal leadership groups, collaborating with Global Manufacturing, Technical Services, and Supply Chain executives to align quality objectives with business growth and product supply continuity.

Your 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 the implementation of standards across internal and external manufacturing networks.
• Establish and govern global quality performance metrics (KPIs) and deploy advanced Quality Risk Management methodologies to drive continuous improvement, operational excellence, and audit readiness.
• Champion a global culture of quality by driving talent development, succession planning, and the sharing of best practices in productivity and operational improvements (i.e., LEAN).
• Ensure effective communication and stakeholder management, serving as the ultimate point of escalation for critical quality issues and ensuring alignment between global quality and site operations.

What You Need to Succeed (minimum qualifications):

• Education: Bachelor's Degree in a scientific or engineering field (e.g., chemistry, microbiology, pharmacy, or physical or biological sciences).
• Experience: A minimum of 15 years of experience in Quality Assurance/Operations within the pharmaceutical or biotechnology industry, with at least 10 years in a senior leadership role.
• Expertise: Deep expertise in biologics and vaccines manufacturing processes, global cGMP standards (FDA, EMA, USDA), and a proven track record of leading international health authority inspections.
• Leadership: Demonstrated success in guiding and developing high-performing quality teams in a global environment.

What will give you a competitive edge (preferred qualifications):

• Advanced degree (Masters or PhD) in Life Sciences, Management, or another relevant scientific field.
• Experience managing quality across a multi-site global network in the Biologics and Vaccines space, with international experience highly valued.
• Proven ability to influence executive stakeholders and navigate complex, matrixed global environments.
• Demonstrated experience in digital quality transformation and the use of advanced data analytics for quality oversight.

Additional Information:

• Travel: 40%
• Location: Indianapolis, IN or Kansas City, MO - Hybrid Work Environment

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.