About the Role
As part of the UCB Quality organization, the Evidence Quality Lead (EQL) enables compliant Research, Development and Pharmacovigilance processes (GLP, GCP, GVP) from candidate to asset delivery, to commercial branding, with a focus on successful global launches and sustainable access for patients. The EQL collaborates with internal teams and external stakeholders to ensure quality by design and maintain continuous inspection readiness.
Responsibilities
Quality Strategy
* Develop and maintain the Quality Strategy at a compound level.
* Create and sustain a quality roadmap for strategic quality objectives covering the clinical development and post‑marketing phases.
* Identify and manage risks using a risk‑based approach across compounds, processes, systems, sites, and vendors.
* Ensure compliance with GxP regulations, guidance, and internal procedures while reducing complexity.
Opportunities to De‑Risk at a Compound Level
* Plan and execute quality activities independently to ensure subject safety and data integrity, complying with protocols and regulations.
* Lead compliance investigations and ensure timely closure of corrective and preventive actions from deviations, audits and inspections.
* Escalate issues early and ensure effective resolution or measures are in place.
* Lead or contribute to complex projects.
* Manage pre‑inspection documentation and quality reviews in collaboration with functional SMEs and global process owners.
Performance Monitoring
* Conduct analytics and qualitative assessments to identify trends.
* Monitor quality deliverables from vendors and partners, sharing updates with internal functions.
* Ensure continuous inspection readiness and integrity of data included in regulatory dossiers.
* Lead or support inspections and investigations, coordinating responses and hosting strategies.
GxP Quality Advisor Responsibilities
* Review and implement updates to GxP legislation, define best practices and assess impact on procedures, systems and contractual arrangements.
* Provide expert advice to mitigate compliance risks or address complex issues.
* Deliver presentations to peers, senior management, and industry audiences.
Qualifications
* Bachelor's degree in a relevant scientific or healthcare‑related field.
* Minimum of 10 years in the (bio)pharmaceutical industry, with at least 5 years in research or clinical development.
* At least 2 years of experience within the ATMP regulatory framework.
* Fluent in English communication (oral and written); additional languages are a plus.
* Proven track record of contributing to gene therapy clinical programs with technical and scientific expertise.
* Ability to translate regulatory and quality expectations into operations, based on knowledge of quality principles.
* Experience in GLP, GCP and/or GVP quality auditing, inspection, compliance management, and/or Medical Device regulations/operations is an asset.
* Ability to drive collaboration and engagement across the stakeholder network, motivating others to achieve results.
* Skilled in influencing others within a global matrix organization and driving informed decision‑making.
* Capable of prioritizing and focusing on critical issues using a risk‑based approach.
* Manages quality and compliance issues with diligence, rigor, transparency and timeliness.
* Strong analytical skills with experience in analyzing and synthesizing complex data.
* Proficient in presenting complex projects and issues clearly and succinctly.
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws. Should you require adjustments to our process to assist you in demonstrating your strengths and capabilities, please contact EMEA-Reasonable_Accommodation@ucb.com.
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