Solutions Quality Lead

Make your mark for patients

To strengthen our Quality Solutions department, we are looking for a talented profile to fill the position of: Solutions Quality Lead – Braine l’Alleud, Belgium

 

About the role

The Solutions Quality Lead is a senior quality leader responsible for implementing quality governance and continuously evolving the nonclinical and translational quality strategy across a global portfolio of candidate programs. The role provides strategic quality leadership across nonclinical safety, quantitative clinical pharmacology, PBPK/model-informed drug development, outsourced vendor oversight, regulatory-document readiness, and inspection-defensible documentation, data, and systems practices. The Lead ensures that phase-appropriate, risk-based quality frameworks are established and maintained to enable high-quality development decisions while preserving scientific agility and regulatory credibility.

You will work with

 

In this role, you will work closely with various stakeholders across multiple functions. You will collaborate with Global Quality Auditing, Quality Systems & Governance, business stakeholders within Research, External Innovation and Operations and Early Clinical Development and Translational Sciences and additional transversal UCB communities. Your role will involve contributing to process improvements, ensuring alignment with UCB Policies and Procedures and regulatory requirements.

In addition, you will be mentoring quality professionals and influencing senior stakeholders across the matrix organization. The role will represent Solutions Quality in strategic portfolio discussions, significant quality-risk evaluations, regulatory and inspection preparedness activities, and decisions impacting development strategy and execution.

What you will do

Strategic Quality Leadership and Portfolio Governance

Continuously improve the non-clinical quality strategy for candidate programs; translate portfolio priorities into risk-based standards, expectations, and governance routines.

Set and implement decision-quality expectations for development teams, ensuring scientific flexibility is preserved while data integrity, regulatory credibility, and patient focus are protected.

Represent Solutions Quality in governance discussions and provide independent Quality perspective on material risks, escalations, inspection exposure, and regulatory-readiness decisions.

Non-Clinical Quality Partnership

•   Direct phase- and risk-appropriate quality approaches across nonclinical safety, clinical pharmacology, and modelling activities.

•   Guide teams on in translating complex scientific work into documentation, records, and controls that are regulatory-defensible and inspection-ready.

•   Facilitate development teams in balancing speed, scientific flexibility, and compliance expectations from early-phase through late-phase development.

Lead and facilitate teams on the integration and appropriate use of RWE data sources in early development, ensuring alignment with scientific intent, regulatory expectations, and contribution to TPP development.

GxP and Study Oversight

•   Lead and provide quality oversight and guidance for nonclinical studies, especially where GLP or regulatory requirements (may) apply, including sponsor oversight practices for outsourced studies.

•   Execute quality expectations for clinical pharmacology / human pharmacology activities, including traceability of protocol-supporting records, analyses, and reports used in regulatory submissions and responses.

•   Drive pragmatic, risk-based application of quality principles to translational, modelling, RWE-derived datasets, and integrated development activities that may cross traditional GxP boundaries.

Proactively identify recurring risks in study conduct, records, systems, or outsourced oversight, drive preventive improvements across non-clinical candidate programs.

Data, Documentation, and Model Governance

•   Shape decision-critical models, code, datasets (including RWE datasets where applicable), reports, and related records to ensure they are maintained in a regulatory-compliant and inspection-defensible manner.

•   Partner with IT and scientific teams on computerized-systems controls, validation expectations, integration points, access controls, and archival/retrievability for development and modelling systems.

•   Strengthen traceability from scientific question to study/design/analysis, interpretation, development decision, and regulatory position.

Shape governance and traceability expectations of RWE data sources, including data source origin, relevance, and linkage to scientific questions and development decisions.

Vendor / CRO Quality Support

•   Collaborate with Vendor Management to provide risk-based oversight of CROs, specialist vendors, and external scientific partners used for nonclinical studies, modelling activities, and other outsourced development work.

•   Collaborate with Vendor Management to set quality expectations for vendor qualification, oversight plans, escalation pathways, issue trending, and readiness for inspection or audit of externally generated data and reports.

Issue Management and Continuous Improvement

•   Ensure cross-functional governance of management of deviations, quality events, documentation gaps, process failures, and CAPAs with focus on patient risk, development impact, data integrity, and regulatory significance across non-clinical candidate programs.

Regulatory and Inspection Support

•   Provide regulatory-ready content to teams preparing briefing books, IND-enabling content, development packages, labelling-related modelling support, and regulatory responses; i.e., quality of substantiation, traceability, and documentation, including appropriate use of RWE to support early development strategy and TPP positioning.

•   Lead cross-functional  inspection readiness for development activities, especially nonclinical, modelling, study oversight, and regulatory-supporting documentation.

GxP Audit Conduct & Management

Conduct audits of Study Reports, Study Phase Reports, Study Plans and Study Plan Amendments to assure the applicable OECD guidelines (when applicable), UCB SOPs and the Analytical Methods have been adhered to and that reported results accurately reflect the raw data according to UCB SOPs and associated controlled documents

As applicable, archive audit documentation per UCB SOPs; e.g., issued audit reports, supporting documentation, QAS, additional documents as expected according to UCB SOPs and associated controlled documents

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

Bachelor’s, master’s degree or an education in a relevant scientific discipline

Strong pragmatic application of GRP, GSP, and GLP, along with non-GxP quality principles across the nonclinical development lifecycle, including the governance of diverse data types such as real-world evidence (RWE), especially in toxicology, immunotoxicology, and outsourced study oversight.

Demonstrated understanding of clinical development and clinical pharmacology study support processes.

Demonstrated understanding of PBPK / PK-PD / model-informed drug development governance, including data, code, reporting, and system controls.

Demonstrated understanding of computerized systems validation, data integrity, and electronic-record controls applicable to diverse scientific data and analysis workflows.

Inspection-readiness or audit leadership experience in R&D settings.

Strong scientific literacy sufficient to engage credibly with toxicologists, immunologists, PK/PD scientists, modelers, regulatory authors, and study teams across emerging and traditional data domains.

Excellent communication skills and the ability to explain quality implications in practical, development-relevant terms.

Proven risk-based decision-making and the ability to distinguish critical quality issues from lower-risk process noise.

Excellent organizational, issue resolution, and matrix leadership skills.

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.

At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description, this role is hybrid with 40% of your time spent in the office, irrespective of your current contractual agreement. Should 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 laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

 

Requisition ID: 93477

Recruiter: Hiba Loutfi

Hiring Manager: Lauren Tochacek

Talent Partner: Sandrine Eelbo

Job Level: MM I

Please consult HRAnswers for more information on job levels.