Full-Time
Quality Assurance Auditor
R&D
Posted on 9/9/2026
Elanco
5,001-10,000 employees
Global animal health pharmaceutical company
No salary listed
Fort Dodge, IA, USA
In Person
Bachelor's, Master's, MD
 Biology & Biotech (1) |
|---|
Get referred to Elanco
See people who can refer or advise you
- Bachelor of Science degree in biology, animal science, pharmacy, or a related field.
- At least 10 years of experience in a quality oversight or monitoring role for veterinary clinical and safety studies regulated by the Food and Drug Administration, United States Department of Agriculture, or Environmental Protection Agency.
- Deep knowledge of Good Laboratory Practice and Good Clinical Practice regulations.
- Proven ability to influence senior scientific leaders.
- Strong understanding of risk management and Quality Systems.
- Execute the site Quality Assurance program in compliance with Food and Drug Administration Good Laboratory Practice regulations under 21 CFR Part 58 and veterinary Good Clinical Practice standards under VICH GL9, while serving as the ERDQA representative to the R&D Site Lead Team.
- Plan and conduct end-to-end internal and third-party audits, including protocol, in-life, data, and final report reviews, to ensure adherence to regulatory requirements and Elanco Quality Systems.
- Provide Sponsor oversight for non-clinical safety and clinical studies conducted at third parties, while maintaining quality standards for R&D GXP equipment, systems, and site procedures.
- Manage the Quality Management System by authoring site Quality procedures, leading investigations into deviations, and overseeing the implementation and suitability of Corrective and Preventive Actions.
- Act as a primary liaison for regulatory authority inspections and external stakeholders.
- Develop and deliver compliance training to R&D and ERDQA teams.
- Master’s in Life Sciences.
- Doctor of Veterinary Medicine.
- Society for Quality Assurance RQAP-GLP certification.
- Experience with IACUC, Biosafety Committees, and Health and Safety protocols.
Elanco is a global animal health company that develops medicines, vaccines, and preventive care products for livestock and pets. Its products include prescription medicines, vaccines, and parasite-control solutions used by veterinarians, farmers, and pet owners to protect animal health and welfare and improve productivity. After separating from Eli Lilly in 2019, Elanco expanded its scale by acquiring Bayer Animal Health in 2020, which broadened its reach in the companion-animal market and added direct-to-consumer capabilities. Its goal is to advance animal health and welfare worldwide by providing effective, accessible products and services while growing sustainably as a standalone company.
Company Size
5,001-10,000
Company Stage
IPO
Headquarters
Greenfield, Massachusetts
Founded
1954
Get referred to Elanco
See people who can refer or advise you
Simplify's Take
What believers are saying
- August 2026 Q2 revenue hit $1.368 billion, up 10%, and guidance rose again.
- Befrena demand ran two times above expectations, supporting Elwood utilization into early 2027.
- August 2026 Seventh Circuit dismissal ended the securities class action, reducing overhang.
What critics are saying
- 2025 restructuring cuts 300 jobs, closes Monheim R&D, and exits Kansas City implants.
- Blackstone’s $315 million XDEMVY revenue-financing liability pressures future cash flow through 2030.
- A failed Befrena scale-up or biologics manufacturing slip would cripple Elanco’s growth thesis.
What makes Elanco unique
- August 2026: Elanco says only two animal-health companies sell monoclonal antibodies commercially.
- Elwood, Kansas expansion lifted mAb capacity over fourfold for Befrena and Trutect.
- May 2026: AHV International acquisition deepened Elanco’s dairy and cattle portfolio.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Flexible Work Hours
Hybrid Work Options
401(k) Company Match
Parental Leave
Annual Bonus
Relocation Assistance
Growth & Insights and Company News
6 month growth
↑ 4%1 year growth
↑ 4%2 year growth
↑ 4%Elanco completes expansion of Kansas biologics facility. September 1, 2026 Elanco Animal Health has completed a 25,000-square-foot expansion of its manufacturing facility in Elwood, Kansas, strengthening its capacity to produce monoclonal antibody (mAb) treatments for companion animals. The expansion was completed on schedule, the company announced on 26 August 2026. The US$120 million investment increases the site's production capacity by more than four times through additional upstream and downstream processing equipment. It also adds a pilot plant for process development and clinical testing materials, a quality control laboratory and additional support areas. Elanco plans to invest a further US$30 million through 2028, including additional warehousing, bringing the total investment to US$150 million. Burns & McDonnell led the design and construction project. The expanded facility comes as Elanco increases its focus on biologics. The company recently began the phased launch of Befrena (tirnovetmab), an anti-IL-31 monoclonal antibody injection for canine allergic and atopic dermatitis. The Elwood site also manufactures Trutect, which received full approval in 2025 as the first and only approved therapeutic solution for canine parvovirus. The expansion comes as pet owners continue to prioritise pet health and wellness despite rising costs. Elanco's survey of 1409 US pet owners, conducted earlier this year, found that pet health and wellness remained a protected spending priority even as costs increased across categories, including higher fuel prices. The trend points to continued demand for treatments and solutions aimed at supporting companion-animal health. "When we announced the expansion two years ago, we recognised that executing the most exciting pipeline in Elanco's history required a manufacturing footprint capable of matching our innovation ambition," said Grace McArdle, Executive Vice President, Manufacturing and Quality. McArdle said the expanded monoclonal antibody capacity will help Elanco meet demand for its animal health products while maintaining a safe and reliable supply. The expansion is also expected to bring jobs to the region. Jeff Simmons, President and CEO, said "With customer demand for Befrena two times above expectations, this expansion was key in ramping capacity to meet demand as we anticipate reaching unconstrained levels in early 2027."
Elanco completes Kansas facility expansion for monoclonal antibodies. The $120 million expansion of Elanco's Elwood, Kansas, U.S., site boosts monoclonal antibody production capacity more than fourfold to support the company's growing biologics pipeline. August 31, 2026 Elanco Animal Health completed a 25,000-square-foot monoclonal antibody manufacturing expansion at its Kansas facility, increasing production capacity more than fourfold with a $120 million investment to meet surging demand for its innovative pet health treatments including Befrena and Trutect. * Expansion scope: 25,000-square-foot facility completed on time at Elwood, Kansas site with fourfold production capacity increase * Investment total: $120 million completed now, plus planned $30 million through 2028 for warehousing (total $150 million) * Key products: Befrena (tirnovetmab) for canine allergies and Trutect for canine parvovirus, both manufactured at the facility * Market position: Elanco is one of only two animal health companies with monoclonal antibody solutions currently on the market * Demand signal: Customer demand for Befrena is two times above expectations, with unconstrained production anticipated by early 2027 Elanco Animal Health Inc. announced the on-time completion of a 25,000-square-foot manufacturing expansion at its Elwood, Kansas, U.S., site. The company said the project strengthens its position as one of only two animal health companies with monoclonal antibody (mAb) solutions currently on the market. "When we announced the expansion two years ago, we recognized that executing the most exciting pipeline in Elanco's history required a manufacturing footprint capable of matching our innovation ambition," said Grace McArdle, executive vice president, manufacturing and quality. "The expanded monoclonal antibody capacity ensures that as Elanco continues to pioneer breakthroughs in animal health, we are ready to meet pet owner and veterinarian demand with a safe and reliable supply," added McArdle. The company said the expansion increases the site's production capacity more than fourfold through new upstream and downstream processing equipment. The $120 million investment also included a new pilot plant to accelerate process development and produce materials for clinical testing, a new quality control laboratory and additional support space. Elanco plans a further $30 million investment through 2028 for additional warehousing, bringing the total investment to $150 million. Antibody-based therapies. Elanco recently announced the phased launch of Befrena (tirnovetmab), an anti-IL-31 mAb injection for treatment of canine allergic and atopic dermatitis. The company's first mAb product, Trutect (formerly Canine Parvovirus Monoclonal Antibody), received full approval in 2025 as the first and only approved therapeutic solution for canine parvovirus. Both products are manufactured at the Elwood facility. "Pets are integral and central to our lives, and Elanco's charge is clear to keep innovating to make life better for animals," said Jeff Simmons, president and CEO. "With customer demand for Befrena two times above expectations, this expansion was key in ramping capacity to meet demand as we anticipate reaching unconstrained levels in early 2027. Our R&D and manufacturing engine is stronger than ever to deliver a consistent flow of high-impact innovation to meet higher pet owner expectation of care now and into the next decade." According to an Elanco survey of 1,409 U.S. pet owners conducted earlier this year, pet health and wellness remain a protected budget item even as costs rise across other spending categories, including gas prices. "Today's milestone reinforces Elanco's commitment to going beyond to deliver differentiated, high-impact innovation in key therapeutic areas," said Dr. Ellen de Brabander, executive vice president, research, development and regulatory affairs. "As we continue to draw insights from monoclonal advancements in human health, we believe that antibody-based therapies have untapped potential in animal health. With the expansion of our Elwood manufacturing site, we are now better positioned to scale the future of our innovation portfolio." Unlock Personalized Content! Sign up and the recommendations below will be more personalized for you!
Ribbon cutting held for Elanco expansion in Elwood. Elanco Animal Health completed a major expansion and renovation of its Elwood manufacturing facility, bringing increased production capacity and 70 new jobs to the area. The 25,000-square-foot expansion has increased production capacity by more than four times through the addition of new equipment. The company plans a broader $150 million investment at the Elwood facility through 2028. Elanco manufactures USDA-approved monoclonal antibody products for canine parvovirus and allergic dermatitis at the site, with additional positions expected as capabilities grow. Local and state officials attended the ribbon-cutting ceremony for the grand opening.
Elanco expands Kansas facility to boost biologics production. 27 August 2026 Elanco has completed a $120 million expansion of its Elwood, Kansas, USA, manufacturing facility. The expanded facility increases monoclonal antibody production capacity to support growing pet owner and veterinarian demand for innovative animal health therapies. Elanco Animal Health Incorporated has announced the on-time completion of a 25,000-square-foot manufacturing expansion of its Elwood, Kansas, USA, manufacturing site. The company notes that, as one of only two animal health companies with monoclonal antibody (mAb) solutions on the market today, the expansion further strengthens Elanco's leadership in the biologics space. "When we announced the expansion two years ago, we recognized that executing the most exciting pipeline in Elanco's history required a manufacturing footprint capable of matching our innovation ambition," said Grace McArdle, Executive Vice President, Manufacturing and Quality at Elanco. "The expanded monoclonal antibody capacity ensures that as Elanco continues to pioneer breakthroughs in animal health, we are ready to meet pet owner and veterinarian demand with a safe and reliable supply. It also brings high demand, impactful jobs to the region. We appreciate the commitment of the State of Kansas, Doniphan County and the City of Elwood to help pets live longer, healthier, more active lives." The company recently announced the phased launch of Befrena(TM)(tirnovetmab), a new anti-IL-31 mAb injection for treatment of canine allergic and atopic dermatitis. In addition to Befrena, Elanco's first mAb product, Trutect(TM)(formerly Canine Parvovirus Monoclonal Antibody), received full approval in 2025 as the first and only approved therapeutic solution for canine parvovirus. Both products are currently manufactured at Elanco's Elwood facility. "Pets are integral and central to our lives and Elanco's charge is clear to keep innovating to make life better for animals," said Jeff Simmons, President and CEO of Elanco. "With customer demand for Befrena two times above expectations, this expansion was key in ramping capacity to meet demand as we anticipate reaching unconstrained levels in early 2027. Our R&D and manufacturing engine is stronger than ever to deliver a consistent flow of high impact innovation to meet higher pet owner expectation of care now and into the next decade." Elanco highlights that this expansion comes at a pivotal time when pet owners' expectations for care are higher than ever. According to Elanco's latest survey of 1,409 U.S. pet owners conducted earlier this year, even with rising costs across spending categories, including higher gas prices, pet health and wellness remain top priorities as a protected budget item[[i]]. The company adds that this prioritization reflects a growing demand for comprehensive portfolios and innovative solutions, such as monoclonal antibodies, that can enhance the quality of life for pets. "Today's milestone reinforces Elanco's commitment to going beyond to deliver differentiated, high impact innovation in key therapeutic areas," said Dr. Ellen de Brabander, Executive Vice President, Research, Development and Regulatory Affairs at Elanco. "As we continue to draw insights from monoclonal advancements in human health, we believe that antibody-based therapies have untapped potential in animal health. With the expansion of our Elwood manufacturing site, we are now better positioned to scale the future of our innovation portfolio." In addition to increasing production capacity of the manufacturing site by more than four times with upstream and downstream processing equipment, this $120 million investment also includes: a new pilot plant to accelerate process development and deliver the materials needed for clinical testing, a new quality control laboratory and additional support spaces. Another $30 million investment is planned through 2028 to include additional warehousing, for a total investment of $150 million. Design-build firm Burns & McDonnell, headquartered in Kansas City, Mo., led the expansion project as the primary provider of integrated design and construction services. References: [i] Elanco Animal Health. Data on File. REF-30035
Elanco scales biologics capabilities with expansion of Kansas manufacturing facility. Aug 26, 2026, 08:30 ET The completed 25,000-square-foot Elwood site expansion bolsters Elanco's monoclonal antibody (mAb) production; supports delivery of next-generation pipeline INDIANAPOLIS, Aug. 26, 2026 /PRNewswire/ - Elanco Animal Health Incorporated (NYSE: ELAN) today announced the on-time completion of a 25,000-square-foot manufacturing expansion of its Elwood, Kansas manufacturing site. As one of only two animal health companies with mAb solutions on the market today, the expansion further strengthens Elanco's leadership in the biologics space. "When we announced the expansion two years ago, we recognized that executing the most exciting pipeline in Elanco's history required a manufacturing footprint capable of matching our innovation ambition," said Grace McArdle, Executive Vice President, Manufacturing and Quality. "The expanded monoclonal antibody capacity ensures that as Elanco continues to pioneer breakthroughs in animal health, we are ready to meet pet owner and veterinarian demand with a safe and reliable supply. It also brings high demand, impactful jobs to the region. We appreciate the commitment of the State of Kansas, Doniphan County and the City of Elwood to help pets live longer, healthier, more active lives." The company recently announced the phased launch of Befrena(TM)(tirnovetmab), a new anti-IL-31 mAb injection for treatment of canine allergic and atopic dermatitis. In addition to Befrena, Elanco's first mAb product, Trutect(TM)(formerly Canine Parvovirus Monoclonal Antibody), received full approval in 2025 as the first and only approved therapeutic solution for canine parvovirus. Both products are currently manufactured at Elanco's Elwood facility. "Pets are integral and central to our lives and Elanco's charge is clear to keep innovating to make life better for animals," said Jeff Simmons, President and CEO. "With customer demand for Befrena two times above expectations, this expansion was key in ramping capacity to meet demand as we anticipate reaching unconstrained levels in early 2027. Our R&D and manufacturing engine is stronger than ever to deliver a consistent flow of high impact innovation to meet higher pet owner expectation of care now and into the next decade." This expansion comes at a pivotal time when pet owners' expectations for care are higher than ever. According to Elanco's latest survey of 1,409 U.S. pet owners conducted earlier this year, even with rising costs across spending categories, including higher gas prices, pet health and wellness remain top priorities as a protected budget item[i]. This prioritization reflects a growing demand for comprehensive portfolios and innovative solutions, such as monoclonal antibodies, that can enhance the quality of life for pets. "Today's milestone reinforces Elanco's commitment to going beyond to deliver differentiated, high impact innovation in key therapeutic areas," said Dr. Ellen de Brabander, Executive Vice President, Research, Development and Regulatory Affairs. "As we continue to draw insights from monoclonal advancements in human health, we believe that antibody-based therapies have untapped potential in animal health. With the expansion of our Elwood manufacturing site, we are now better positioned to scale the future of our innovation portfolio." In addition to increasing production capacity of the manufacturing site by more than four times with upstream and downstream processing equipment, this $120 million investment also includes: a new pilot plant to accelerate process development and deliver the materials needed for clinical testing, a new quality control laboratory and additional support spaces. Another $30 million investment is planned through 2028 to include additional warehousing, for a total investment of $150 million. Design-build firm Burns & McDonnell, headquartered in Kansas City, Mo., led the expansion project as the primary provider of integrated design and construction services. ABOUT ELANCO 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 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help 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 purpose - all to Go Beyond for Animals, Customers, Society and Our People. Learn more at www.elanco.com. i Elanco Animal Health. Data on File. REF-30035 Investor Contact: Tiffany Kanaga (765) 740-0314 [email protected] Media Contact: McKenna Shuler (317) 348-3165 [email protected] SOURCE Elanco Animal Health