Biotech Quality Assurance Lead, Capital Projects

Elanco Tiergesundheit AG; Indianapolis (IN); On-site; USD 110,000 - 155,000; Full time

Job summary

Elanco is seeking a Quality Assurance Advisor to support the Biotech Network, focusing on capital projects, commissioning, and qualification of facilities, utilities and equipment. You will lead QA activities across projects and ensure regulatory compliance with US/EU standards.

The role requires a BS in science/engineering with 10+ years in regulated QA/validation, and experience with cGMPs, tech transfer, and cross-functional collaboration.

Qualifications

• Bachelor's degree in science or engineering (required).
• 10+ years in quality, engineering, or validation in regulated industry.
• Thorough knowledge of US/EU pharma cGMPs, FDA/USDA/EU regulations.
• Strong leadership, coordination, and communication skills.
• Experience with tech transfer, validation, and regulatory documentation.

Responsibilities

• Act as QA representative in capital project activities within Biotech Network.
• Lead design, commissioning, qualification, and validation of facilities and equipment.
• Review and approve documentation (DQ, IQ, OQ, PQ, etc.).
• Ensure compliance with USDA, FDA, EMA requirements; liaise with partners.

Skills

Quality Assurance

Regulatory Compliance

Leadership

Analytical Skills

Documentation

Communication

Project Management

Cross-functional Collaboration

Education

Bachelor's degree in science or engineering

MSc or PhD in Chemistry or Biopharmaceuticals

Tools

SAP

JMP

Veeva Vault

Microsoft Office

Job description

Elanco is seeking a Quality Assurance Advisor to support the Biotech Network, focusing on capital projects, commissioning, and qualification of facilities, utilities and equipment. You will lead QA activities across projects and ensure regulatory compliance with US/EU standards.

The role requires a BS in science/engineering with 10+ years in regulated QA/validation, and experience with cGMPs, tech transfer, and cross-functional collaboration.