Elanco · 22 hours ago
USDA Quality Advisor, Biotech Network
Indianapolis, IN
Full-time
Hybrid
Senior Level, Lead/Staff
10+ years expElanco is a global leader in animal health dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. The USDA Quality Advisor, Biotech Network will ensure robust support for Quality processes related to USDA licensure, focusing on regulatory submissions and deviation management while driving continuous improvement in quality performance across multiple sites.
ManufacturingPetSupply Chain Management
Hiring Manager
Katie Greene
Responsibilities
Help define strategic action plans and priorities for the Quality agenda to drive continuous improvement. Provide tactical support for Quality Assurance and compliance processes and initiatives
Act as an Alternate Liaison for Elanco’s USDA Establishment, managing submissions and interactions with USDA-CVB
Leverage external benchmarking and networking to pinpoint strategic improvements for Compliance and overall performance. Construct robust business cases, articulate strong rationales and value propositions, and champion these projects/initiatives for Senior Leader approval
Serve as a key team player in Deviation Review Boards, guiding investigations and driving excellence in deviation handling
Coach and mentor colleagues in technical writing for regulatory submissions, conduct on-site visits to assess Quality System effectiveness and lead sites through optimization initiatives
Qualification
Required
Bachelor's degree in biochemistry, chemistry, virology, biology, or a science-related field
A minimum of 10 years of experience in the vaccine/Biotech industry
Thorough knowledge of regulatory requirements for Biotech products (USDA 9CFR, FDA, EU-GMP) and deep technical knowledge of manufacturing processes and analytical methods for Biotech products, including Sterility Assurance
Preferred
Master's or PhD in biochemistry, chemistry, virology, biology, or a science-related field
Demonstrated coaching and mentoring capabilities
Ability to set up partnerships with relevant functions to resolve quality and compliance issues
Versatility in conflict resolution, problem-solving, and working with cross-functional teams
Experience with external benchmarking and networking to identify improvement opportunities
Benefits
Multiple relocation packages for eligible positions
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
Flexible work arrangements
9 Employee Resource Groups
Annual bonus offering
Up to 6% 401K matching
Company
Elanco
Elanco is an animal health company that manufactures and markets a diverse range of products to promote animal health and well-being.
5001-10000 employees
H1B Sponsorship
Elanco has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
Funding
Current Stage
Public CompanyTotal Funding
$252.86MKey Investors
AncoraBill & Melinda Gates Foundation
2023-12-30Post Ipo Equity· $250M
2018-09-19IPO
2017-05-24Grant· $2.86M
Leadership Team
Dave Kinard
Executive Vice President Human Resources, Corporate Affairs & Administration
Jennifer Black
Senior Director, Global Indirect Procurement
Recent News
2026-01-03
2025-12-18
Company data provided by crunchbase