Project Quality Lead, Engineering

Make your mark for patients

We are looking for an 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.

Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.

Unless explicitly stated in the description, this role is hybrid with 40% of your time spent in the office, regardless of your current contractual agreement. If your current working arrangements differ, please contact your Talent Partner to discuss before submitting your application.

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 US-Reasonable_Accommodation@ucb.com 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.

Requisition ID: 93137

Recruiter: Parth Suthar

Hiring Manager: Pascal Thom

Talent Partner: Sandrine Eelbo

Job Level: MM I

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