Manager - Hub QA

Elanco Tiergesundheit AG; Fort Dodge (IA); On-site; USD 90,000 - 140,000; Full time

Job summary

Elanco is seeking a Manager, Hub Quality for the Fort Dodge hub to provide quality leadership and regulatory oversight across incoming inspection, storage, packaging, and release operations. You will oversee supplier quality and lead cross-functional teams to ensure compliance with quality systems and regulatory requirements.

The role requires a Bachelor's in a science field and at least 5 years in regulated pharmaceutical or vaccine manufacturing with strong leadership and risk-based

Qualifications

• Bachelor's degree in biology, chemistry, or another science field.
• Experience in regulated pharma/vaccine manufacturing and leadership of technical teams.
• Strong knowledge of cGMP/GLP and USDA/FDA requirements.

Responsibilities

• Provide leadership and development for the Hub Quality team and uphold the Quality Management System.
• Oversee quality systems including deviations, investigations, CAPA, complaints, change controls, SOPs, and escalation.
• Lead incoming material quality, sampling, release, storage, packaging and labeling operations, and finished goods release.
• Own the site Supplier Quality program, including supplier approvals, audits, CAPAs, and change notifications.
• Collaborate with Operations, Engineering, Regulatory, Procurement, R&D, and Global Quality teams to manage risk and drive improvements.

Skills

Leadership

Quality systems

Regulatory knowledge

Cross-functional

Education

Bachelor's degree in biology, chemistry, or related

Tools

SAP

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:

Manager, Hub Quality. As the Manager, Hub Quality, you will provide quality leadership and technical oversight for the Fort Dodge Hub Warehouse, supporting incoming inspection, material storage and handling, packaging and labeling operations, and supplier quality. In this role, you will lead the Hub Quality team, ensure compliance with regulatory and Elanco quality requirements, and drive continuous improvement across quality systems and warehouse operations.

Your Responsibilities:

• Provide leadership, technical guidance, training, and development for the Hub Quality team while ensuring effective execution of the Quality Management System and continued inspection readiness.
• Oversee quality systems including deviations, investigations, CAPA, complaints, change controls, SOPs, and escalation of significant quality and compliance issues.
• Lead quality oversight for incoming materials, raw material sampling and release, material storage and control, packaging and labeling operations, and finished goods batch release.
• Own the site Supplier Quality program, including supplier approvals, risk assessments, quality agreements, audit planning and responses, supplier CAPAs, and change notifications.
• Partner cross-functionally with Operations, Engineering, Regulatory, Procurement, R&D, Affiliate Quality, and Global Quality teams to manage compliance risks, support audits and inspections, and drive quality and process improvement initiatives.

What You Need to Succeed (minimum qualifications):

• Education: Bachelor's degree in biology, Chemistry, or another science-related field.
• Experience: Minimum of 5 years of experience in regulated pharmaceutical and/or vaccine manufacturing, including experience with quality oversight and leadership of technical teams.
• Skills: Strong knowledge of cGMP/GLP and USDA/FDA regulatory requirements; demonstrated ability to lead and develop technical teams, make risk-based quality decisions, and communicate effectively across functions and organizational levels.

What Will Give You a Competitive Edge (preferred qualifications):

• Experience with warehouse quality operations, incoming material inspection and release, packaging and labeling, and finished goods batch release.
• Experience managing supplier quality programs, including supplier qualification, audits, risk assessments, quality agreements, and CAPA.
• Experience leading investigations, deviations, CAPA, change controls, and regulatory or corporate audit responses.
• Knowledge of SAP quality data, quality systems, statistics, databases, and risk-management principles.
• Demonstrated success leading cross-functional quality initiatives and continuous improvement projects within a regulated manufacturing 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.