Manager - Hub QA

Elanco in; Fort Dodge (IA); On-site; USD 90,000 - 130,000; Full time

Job summary

Elanco seeks a Manager, Hub Quality for the Fort Dodge Hub Warehouse to lead quality operations across incoming inspection, storage, packaging, and batch release. You will ensure compliance with regulatory requirements and drive continuous improvement in quality systems.

The role requires 5+ years in regulated pharmaceutical manufacturing with strong cGMP/GLP and supplier quality experience, plus cross-functional collaboration across functions to mitigate risk.

Qualifications

• Bachelor's degree in biology, chemistry, or a related science field.
• Minimum 5 years in regulated pharma/vaccine manufacturing with quality oversight and leadership.
• Strong knowledge of cGMP/GLP and USDA/FDA requirements; ability to lead cross-functional teams.

Responsibilities

• Provide leadership, technical guidance, training, and development for the Hub Quality team.
• Oversee quality systems including deviations, investigations, CAPA, complaints, change controls, SOPs, and escalation of issues.
• Lead quality oversight for incoming materials, raw material sampling and release, storage and packaging operations, and finished goods release.
• Own the site Supplier Quality program including supplier approvals, risk assessments, quality agreements, audits, supplier CAPAs, and change notifications.
• Partner cross-functionally with Operations, Engineering, Regulatory, Procurement, R&D, Affiliate Quality, and Global Quality to manage risks and drive improvements.

Skills

Quality leadership

cGMP/GLP

Regulatory knowledge

CAPA

Supplier quality

Education

Bachelor's degree in biology/chemistry or related science

Tools

SAP quality data

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!

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.