Executive Director, Quality

Elanco US; United States; Remote; USD 182,000 - 273,000; Full time

Benefits offered by this job

Company bonus

401(k) matching

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Prescription drug benefits

Flexible benefits

Job summary

Elanco is seeking an Executive Director of Quality - Global Biologics Network to provide strategic leadership for the worldwide biologics manufacturing quality program. You will define and execute the global quality strategy, mitigate risks, and ensure robust quality performance across internal biologics manufacturing sites in accordance with cGMP and USDA standards.

You will lead health authority inspection readiness, establish KPIs, and drive continuous improvement while aligning quality

Qualifications

• Bachelor's Degree in a scientific or engineering field.
• Minimum 15 years of experience in Quality Assurance/Operations within the pharmaceutical or biotechnology industry, with at least 10 years in a senior leadership role.
• Deep expertise in biologics and vaccines manufacturing processes, global cGMP standards (FDA, EMA, USDA), and proven track record of leading international health authority inspections.
• Leadership experience guiding and developing high-performing quality teams in a global environment.

Responsibilities

• Lead the global quality strategy, risk management framework, and product life cycle management for the Biologics Manufacturing network.
• Oversee Health Authority inspection readiness programs across all biologics sites and drive standards across networks.
• Establish and govern global quality performance metrics (KPIs) and deploy Quality Risk Management methodologies.
• Champion a global culture of quality, talent development, succession planning, and lean productivity improvements.
• Ensure effective communication and escalation for critical quality issues, aligning global quality with site operations.

Skills

Quality Assurance

Operations leadership

Global quality strategy

Regulatory inspections

Cross-functional collaboration

Education

Bachelor's Degree in a scientific or engineering field

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; Kansas City, MO; or US- Remote

Elanco currently anticipates that the base salary for this position could range from $181,700 to $272,600 depending partly on the successful candidate's qualifications, including education and experience.

Full-time equivalent employees also will be eligible for a company bonus (depending partly on company and individual performance).

Additionally, Elanco offers a comprehensive benefit program to eligible employees that includes a company-matching 401(k); vacation benefits; eligibility for medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dep