Engineering Quality Lead for Biopharma Projects

UCB; Atlanta (GA); Hybrid; USD 148,000 - 194,000; Full time

Job summary

UCB in Atlanta is seeking a Project Quality Lead, Engineering for the BioNexUS program. This hybrid role requires in-office presence at least 40% and up to 20% travel internationally and domestically.

You will lead quality oversight for engineering activities from design through execution to ensure regulatory compliance. You will collaborate with Engineering, Project Management, Manufacturing, and Quality, shaping quality strategy for a flagship US biologics footprint and ensuring data integrity

Qualifications

• Master's degree in Engineering or related field.
• 8+ years in GMP-regulated quality, engineering quality, qualification or validation in pharma/biotech manufacturing.
• Experience supporting large capital projects (greenfield or major expansions).
• Strong knowledge of FDA/EMA regulatory expectations.

Responsibilities

• Act as the quality partner across engineering workstreams from design through qualification.
• Apply quality by design with a phase-appropriate, risk-based approach per cGMP and UCB standards.
• Review and approve key deliverables including URS, design docs, risk assessments, and qualification reports.
• Lead Installation, Operational, and Performance Qualification activities for facilities, equipment, utilities, and systems.
• Ensure designs incorporate cleaning validation strategies.
• Oversee vendor quality, including qualification, audits, and agreements.
• Develop and approve SOPs and controlled documents across engineering, validation, lifecycle mgmt.
• Provide guidance on digital and automated solutions ensuring data integrity.
• Identify and mitigate regulatory risks (FDA, EMA).
• Support inspection readiness and regulatory interactions.

Skills

Quality leadership

Regulatory knowledge

Risk assessment

Cross-functional collaboration

Digital systems knowledge

Education

Master's degree in Engineering

Tools

GxP standards

Job description

UCB in Atlanta is seeking a Project Quality Lead, Engineering for the BioNexUS program. This hybrid role requires in-office presence at least 40% and up to 20% travel internationally and domestically.

You will lead quality oversight for engineering activities from design through execution to ensure regulatory compliance. You will collaborate with Engineering, Project Management, Manufacturing, and Quality, shaping quality strategy for a flagship US biologics footprint and ensuring data integrity