Executive Director, Quality

Elanco Tiergesundheit AG; Indianapolis (IN); Hybrid; USD 210,000 - 260,000; Full time

Benefits offered by this job

Hybrid work environment

Travel 40%

Job summary

Elanco Animal Health Incorporated seeks an Executive Director of Quality for the Global Biologics Network in the United States. You will define and execute the global quality strategy across biologics manufacturing sites, ensuring cGMP compliance and readiness for Health Authority inspections.

You will lead cross-functional teams, drive risk-based quality improvements, and champion a culture of quality, LEAN, and continuous development. Travel expected with a hybrid work model.

Qualifications

• Bachelor's Degree in a scientific or engineering field.
• Minimum 15 years in Quality Assurance/Operations with at least 10 years in a senior leadership role.
• Deep expertise in biologics and vaccines manufacturing, global cGMP standards (FDA, EMA, USDA), and proven leadership of international inspections.
• Proven ability to guide and develop high-performing global quality teams.

Responsibilities

• Direct the global quality strategy and lifecycle for the Biologics network, aligning with international cGMP and USDA standards.
• Lead health authority inspection readiness across biologics sites and coordinate with Compliance to implement standards.
• Establish KPIs and apply Quality Risk Management to drive improvement and audit readiness.
• Foster global quality culture through talent development and LEAN process improvements.
• Ensure clear communication with stakeholders and escalation for critical quality issues.

Skills

Quality Assurance

Operations Leadership

Biologics

cGMP

Education

Bachelor's Degree

Job description

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.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose CSR framework - all to advance the health of animals, people and the planet. Learn more at www.elanco.com.