Biotech Network QA Leader (Capital Projects)

Elanco Tiergesundheit AG; United States; Remote; USD 110,000 - 170,000; Full time

Job summary

Elanco seeks a Biotech Network Advisor, Quality Assurance, to support capital project activities and supplier quality across the Biotech Network. You will participate in design, commissioning, qualification, and validation of facilities, utilities, and equipment, ensuring adherence to regulatory requirements.

The role requires a Bachelor's in science/engineering, 10+ years in quality or validation, and strong leadership, communication, and analytical skills.

Qualifications

• Bachelor's degree in a science or engineering discipline and 10+ years in quality, engineering, or validation in regulated industry.
• Thorough knowledge of US/EU cGMPs, FDA, USDA, VICH, and EU regulations related to manufacturing, quality, and release.
• Strong leadership, teamwork, organizational and interpersonal skills; excellent written and verbal communication.

Responsibilities

• Act as QA representative in local and major capital project activities within the Biotech Network.
• Participate in design, commissioning, qualification, and validation activities for major projects.
• Support QA in defining needs for QC laboratories and compliance.
• Ensure capital projects meet regulatory requirements (USDA, FDA, EMA) and align with partner standards.
• Provide leadership to QA staff and collaborate across R&D, Manufacturing, Engineering, and Supply Chain.

Skills

Leadership

Attention to detail

Analytical skills

Communication skills

Interpersonal skills

Project leadership

Education

Bachelor's degree in science or engineering

MSc or PhD in Chemistry/Bio/Pharmaceutical Technology or related

Tools

SAP

JMP

Veeva Vault

Microsoft Office

Job description

Elanco seeks a Biotech Network Advisor, Quality Assurance, to support capital project activities and supplier quality across the Biotech Network. You will participate in design, commissioning, qualification, and validation of facilities, utilities, and equipment, ensuring adherence to regulatory requirements.

The role requires a Bachelor's in science/engineering, 10+ years in quality or validation, and strong leadership, communication, and analytical skills.