Project Quality Lead, Engineering

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

Make your mark for patients We are looking for a Project Quality Lead, Engineering who is strategic, collaborative, and driven by impact to join our BioNexUS Program Team. This hybrid position (at least 40% of the time in office) is based in Atlanta, Georgia and requires up to 20% domestic & international travel.

About The Role

You will operate in a pivotal leadership role within the BioNexUS project, UCB's multi-billion-dollar greenfield investment to build a next-generation biologics manufacturing facility in the metropolitan Atlanta area, Georgia (USA). This role is instrumental in ensuring that quality is embedded by design throughout the project lifecycle. Reporting to the BioNexUS Quality Lead, the position provides quality oversight for all engineering activities during design and execution, ensuring compliance with regulatory requirements, UCB standards, and project objectives. This role offers a unique opportunity to shape quality strategy and practices for a flagship UCB investment, contributing directly to patient safety, regulatory readiness, and the long-term success of UCB's U.S. biologics manufacturing footprint.

You will work with

As the quality authority for engineering disciplines, you will work closely with Engineering, Project Management, Manufacturing, Commissioning & Qualification, Quality functions, and external suppliers across the BioNexUS project, as well as with UCB's global functions. Together with BioNexUS Quality Lead and Quality Lead Digital, you will help shape UCB's future biomanufacturing quality approach. As part of the global Engineering Quality team, you will collaborate with peers across major CapEx projects and global Engineering Quality Leads to align and harmonize engineering quality standards and ways of working.

What You Will Do

• Act as the quality partner across engineering workstreams (premises, equipment, utilities) from design through qualification.
• Ensure quality by design using a phase-appropriate, risk-based approach aligned with current Good Manufacturing Practice requirements and UCB standards.
• Review and approve key deliverables, including User Requirements Specifications, design documents, risk assessments, and commissioning and qualification strategies and reports, providing quality oversight.
• Lead qualification activities (Installation, Operational, and Performance Qualification) for facilities, equipment, utilities, and systems.
• Ensure designs incorporate cleaning validation strategies.
• Oversee vendor quality , including qualification, audits, and agreements.
• Develop and approve Standard Operating Procedures and controlled documents across engineering, validation, and lifecycle management.
• Provide guidance on digital and automated solutions, ensuring compliance and data integrity.
• Identify and manage quality and regulatory risks, ensuring timely mitigation (FDA, EMA).
• Support inspection readiness and regulatory interactions (Food and Drug Administration, European Medicines Agency, and other health authorities).

Interested? For this position you’ll need the following education, experience and skills

• Master's degree in Engineering or a related scientific field (or equivalent experience).
• 8+ years of experience in Good Practice regulated quality, engineering quality, qualification, or validation in pharmaceutical or biotechnology manufacturing.
• Experience supporting large capital projects (greenfield or major expansions preferred).
• Strong knowledge of current Good Manufacturing Practice and regulatory expectations (Food and Drug Administration, European Union).
• Experience with commissioning, qualification, and vendor oversight.
• Familiarity with American Society for Testing and Materials E2500, International Society for Pharmaceutical Engineering Baseline Guide Volume 5, and Good Automated Manufacturing Practice 5 is a plus.
• Ability to assess risk, solve problems pragmatically, and manage complexity.
• Strong understanding of digital, automated, and computerized systems and data integrity principles.
• Excellent communication and collaboration skills.
• Proactive, structured, and adaptable in a fast-paced environment.

The reasonably anticipated salary range for this position is $ 148,000-194,300 per year. The actual salary offered will take into account related knowledge, skills, experience and location among other factors and may fall outside the expected range.

About Us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?

At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We go beyond to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless explicitly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [e-mail] for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.