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Senior Quality Advisor R&D Technical Development

Job

Elanco

Indianapolis, IN (In Person)

Full-Time

Posted 5 weeks ago (Updated 4 weeks ago) • Actively hiring

Expires 5/28/2026

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Job Description

Senior Quality Advisor
  • R D Technical Development 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:
Senior Quality Advisor
  • R D Technical Development As a Quality Advisor, you will be part of Elanco's R D Quality Assurance organization, providing global quality leadership and GMP compliance guidance to support technical development, product registration, and successful product launches.
In this role, you will partner closely with R D, Technical Services, Engineering, and external partners to ensure compliant, risk-based, and fit-for-purpose solutions that enable innovation while meeting global regulatory expectations.
Your Responsibilities:
  • Provide end-to-end quality oversight for equipment, facilities, utilities, and computerized systems, including review and approval of commissioning and qualification documentation (IQ/OQ/PQ), ensuring systems are designed, installed, and operated in alignment with GxP requirements and validated user needs.
  • Partner with global R D, Technical Services/Manufacturing Science (TS/MS), Engineering, and project teams to apply scientific and technical expertise in developing practical, risk-based, and customer-oriented solutions to complex development, scale-up, and process quality challenges.
  • Establish and execute quality and compliance strategies across development programs, including scientific review and approval of GxP documentation (pre-clinical, clinical, CMC, protocols, reports, investigations, and development materials) to support regulatory submissions and product registration.
  • Ensure global inspection readiness by conducting and supporting internal audits, self-inspections, and third-party oversight (CMOs, CROs, suppliers), managing Quality Agreements, driving CAPA effectiveness, and coordinating preparation for regulatory authority inspections.
  • Build and maintain strong cross-functional relationships and influence stakeholders across R D, Quality, Engineering, and external partners, providing training, guidance, and leadership to drive compliant decision-making and successful project execution without direct authority. What You Need to Succeed (minimum qualifications):
Education:
Ph.D. in Life Sciences, Phar...
Rate:
150000
Location:
Indianapolis, US-IN Type:
Permanent Industry:
Management Recruiter:
Elanco Contact:
Not Specified Email:
to view click here
Reference:
R0024608
Posted:
2026-04-11 08:23:08
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