Biotech Network QA Lead — Capital Projects & Compliance

Elanco Tiergesundheit AG

Northern (KY)

Hybrid

USD 120,000 - 190,000

Full time

6 days ago

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Job summary

Elanco Tiergesundheit AG is seeking a seasoned Quality Assurance Advisor to lead QA activities for Biotech Network capital projects and supplier quality programs. The role emphasizes design, commissioning, commissioning, and validation of facilities, utilities, and equipment, while ensuring regulatory compliance across USDA, FDA, and EMA standards.

You will provide guidance on validation documentation (DQ, IQ, OQ, PQ), support process validation, and collaborate with R&D, Manufacturing, and

Qualifications

Bachelor's degree in science or engineering.
10+ years' experience in quality, engineering, or validation in a regulated industry.
Thorough knowledge of US/EU cGMPs, FDA, USDA, VICH, and EU regulations related to manufacturing, quality, and release.
Strong leadership, team building, organizational and interpersonal skills.
Experience with SAP, Veeva Vault and validation/documentation processes.

Responsibilities

Act as QA representative in capital project activities within the Biotech Network.
Lead design, commissioning, qualification, and validation for major projects.
Review and approve validation plans/protocols, design specs, and IQ/OQ/PQ documents.
Support materials management and supplier quality programs across sites.
Mentor QA staff and align local processes with Elanco standards.
Ensure compliance with USDA, FDA, EMA and local regulatory requirements.