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Manager, Quality Assurance (Process Team)
- Fort Dodge, Iowa, United States
- Fort Dodge, Iowa, United States
Über
At Elanco 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 RoleAs a Manager, QA (Process Team), you will be part of Elanco Animal Health's Quality Assurance organization, providing leadership to ensure GMP compliance and technical excellence across manufacturing process teams. In this role, you will drive a proactive quality culture by developing talent, leading quality systems, and partnering with operations to deliver compliant, risk-based, and efficient manufacturing outcomes.
Your Responsibilities:- Lead and develop a high-performing QA team, focusing on technical capability, problem-solving, and independent quality oversight
- Provide QA oversight across process teams (Filling, Bacterins/Media, Virus/Cell, Blending/Equipment Prep, Quality Control) ensuring GMP compliance
- Manage quality systems and lifecycle events (Deviations, CAPAs, Change Controls) within Veeva, ensuring timely and compliant execution
- Support audits (internal, corporate, regulatory) and lead investigation, root cause analysis, and CAPA effectiveness
- Drive operational excellence through Gemba walks, quality metrics, and cross-functional collaboration to improve Right First Time (RFT) performance
- Education: Associate degree required; bachelor's degree in a science-related field preferred
- Required Experience: A minimum of 5 years of experience in regulated pharmaceutical or vaccine manufacturing
- Top 2 skills: Strong GMP/regulatory knowledge (FDA/USDA, aseptic processing) and leadership capability in developing technical teams
- Experience with SAP, Veeva, and Microsoft Office tools
- Prior experience with APHIS/USDA submissions and Outline of Production review
- Knowledge of Lean/Six Sigma methodologies
- Experience influencing cross-functional teams and driving quality culture initiatives
- Strong background in audit readiness and regulatory inspections
- Travel: Minimal
- Location: Fort Dodge, IA Manufacturing Site
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
- Multiple relocation packages
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
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.
Sprachkenntnisse
- English
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