Biotech Quality Assurance Lead, Capital Projects

elanco; United States; Presencial; USD 150 000 - 190 000; Tempo integral

Resumo da oferta

Elanco is seeking a Biotech Network Advisor, Quality Assurance to drive capital projects, supplier quality, and validation activities across the Biotech Network. You will lead QA reviews, support design, commissioning, qualification, and ensure cGMP compliance.

This role requires a science or engineering degree, 10+ years in regulated industries, and experience with SAP/JMP/Veeva Vault; international regulatory knowledge is a plus; minimal travel.

Qualificações

• 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 US and EU cGMPs, FDA, USDA, VICH, and EU regulations related to manufacturing, quality, and release activities.
• Strong leadership, team building, organizational, and interpersonal skills; high attention to detail.
• Experience with SAP, JMP, Veeva Vault.

Responsabilidades

• 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; define scope, develop options, establish user requirements, select equipment, oversee construction, support validation.
• Assist in defining needs for Quality Control testing laboratories and compliance needs.
• Ensure design and execution of capital projects consider USDA, FDA, and EMA regulatory and quality requirements; provide interpretation of standards and align with partners.
• Act as a QA subject matter expert in project teams and committees.
• Review, revise, and approve relevant documentation including user requirements, design specifications, DQ, SAT, FAT, IQ, OQ, PQ, PFDs, safety and environmental assessments, validation plans/protocols.
• Support the creation, review, and implementation of quality standards and procedures for new facilities, utilities, equipment, and manufacturing processes.

Conhecimentos

Leadership

Analytical

Communication

Detail-oriented

Formação académica

Bachelor's degree in science/engineering

MSc/PhD in related field

Ferramentas

SAP

JMP

Veeva Vault

Descrição da oferta de emprego

Elanco is seeking a Biotech Network Advisor, Quality Assurance to drive capital projects, supplier quality, and validation activities across the Biotech Network. You will lead QA reviews, support design, commissioning, qualification, and ensure cGMP compliance.

This role requires a science or engineering degree, 10+ years in regulated industries, and experience with SAP/JMP/Veeva Vault; international regulatory knowledge is a plus; minimal travel.