Solutions Quality Lead

Make your mark for patientsTo strengthen our Quality Solutions department, we are looking for a talented profile to fill the position of: Solutions Quality Lead – Braine l’Alleud, BelgiumAbout the roleThe 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 withIn 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 doStrategic Quality Leadership and Portfolio GovernanceContinuously 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