Quality Assurance Advisor, Biotech Network Capital Projects

Elanco

United States

On-site

USD 110,000 - 150,000

Full time

6 days ago

Be an early applicant

Application generator

An application made for this job — a tailored resume and cover letter that speak straight to the posting.

Get past ATS filters

Job summary

Elanco, a global leader in animal health, is seeking a Biotech Network Advisor to support capital project quality and supplier quality across the Biotech Network. You will review commissioning, qualification, and validation documents and guide QA staff to ensure cGMP compliance at multiple sites.

The role requires 10+ years in quality/validation, strong regulatory knowledge, and excellent cross-functional collaboration.

Qualifications

Bachelor's degree in science or engineering required.
10+ years' experience in quality, engineering, or validation in regulated industry.
Thorough knowledge of US/EU cGMPs, FDA, USDA, VICH and EU regulations.
Strong leadership, organizational and interpersonal skills.
Knowledge of biopharmaceutical operations and tech transfer.
Excellent written and verbal communication; MS Office proficiency.
Ability to collaborate across multiple departments and levels.

Responsibilities

Act as QA representative in capital project activities within Biotech Network.
Participate in design, commissioning, qualification, and validation of major projects.
Assist in defining needs for QA testing laboratories and compliance.
Ensure regulatory compliance (USDA, FDA, EMA) in design and execution.
Provide leadership to QA staff engaged in capital projects and tech transfer.
Review and approve validation plans, protocols, and reports.
Support development of quality standards for new facilities and processes.
Collaborate with R&D, Manufacturing, Engineering, Supply Chain and TSMS.