Manager - Hub QA
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.
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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
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