Biotech QA Advisor: Capital Projects & Compliance

Elanco; Indianapolis (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Elanco Biotech Network seeks a seasoned Quality Assurance Advisor to support capital project activities, qualification of facilities, utilities, and equipment, and ensure compliance with US/EU regulations. You will lead QA involvement across design, commissioning, validation, and technology transfer for biopharma operations.

You will mentor QA staff, review critical documentation, and align processes with Elanco standards while partnering with R&D, Manufacturing, and Supply Chain.

Qualifications

• Bachelor's degree in a science or engineering discipline.
• 10+ years' experience in quality, engineering, or validation roles in a regulated industry.
• Thorough knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, and EU regulations as related to manufacturing, quality, and release activities.
• Strong leadership, team building, organizational, and interpersonal skills. High attention to detail.
• Knowledge and understanding of biopharmaceutical and pharmaceutical operations.
• Analytical Skills: Highly analytical and strong advocate for process improvement.
• Excellent written and verbal communication skills with internal and external customers, peers, and managers.
• Excellent computer, documentation, and organizational skills required.
• Demonstrated ability to work collaboratively and across multiple departments and organization levels. Experience with Microsoft Office (Word, Excel, PowerPoint, Outlook).

Responsibilities

• Act as the Quality Assurance representative in all local and major capital project activities within the Biotech Network.
• Participate in design, development, execution, commissioning, qualification, and validation activities for major projects including requirements, design options, equipment selection, construction oversight, commissioning, qualification, and process validation.
• Assist in defining needs for Quality Control testing laboratories and compliance needs of the same.
• Ensure design and execution of capital projects consider USDA, FDA, and EMA regulatory and quality requirements; provide interpretation of standards and influence with partners.
• Act as a QA subject matter expert in project teams and committees.
• Review, revise, and approve documentation including user requirements, design specs, DQ, SAT, FAT, IQ, OQ, PQ, PFDs, safety and environmental assessments, validation plans/protocols.
• Support creation, review, and implementation of quality standards for facilities, utilities, equipment, and processes; align with Elanco standards.
• Support computer system validation activities including review and approval of validation protocols and reports.
• Partner with R&D, Manufacturing, Engineering, Supply Chain, and TSMS to support technology transfer of new mAb products.
• Review and approve change management plans and complete/verify action items.
• Identify risks, variability sources, and opportunities for improvement to maximize project success.
• Provide leadership to Quality staff engaged in capital projects and technology transfer.
• Demonstrate adherence to regulatory requirements and cGMP standards; embody Safety First and Quality Always.
• Attend required training to stay current with industry standards.
• Guide adherence to materials management and supplier quality; help develop functional standards and procedures.

Skills

Leadership

Analytical thinking

Communication

Regulatory understanding

Education

Bachelor's degree in science/engineering

MSc/PhD preferred

Tools

SAP

JMP

Veeva Vault

Job description

Elanco Biotech Network seeks a seasoned Quality Assurance Advisor to support capital project activities, qualification of facilities, utilities, and equipment, and ensure compliance with US/EU regulations. You will lead QA involvement across design, commissioning, validation, and technology transfer for biopharma operations.

You will mentor QA staff, review critical documentation, and align processes with Elanco standards while partnering with R&D, Manufacturing, and Supply Chain.