Ph3About the Role /h3 /brpAs 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. /p /brh3Responsibilities /h3 /brh3Quality Strategy /h3 /brul /brliDevelop and maintain the Quality Strategy at a compound level. /li /brliCreate and sustain a quality roadmap for strategic quality objectives covering the clinical development and post‑marketing phases. /li /brliIdentify and manage risks using a risk‑based approach across compounds, processes, systems, sites, and vendors. /li /brliEnsure compliance with GxP regulations, guidance, and internal procedures while reducing complexity. /li /br /ul /brh3Opportunities to De‑Risk at a Compound Level /h3 /brul /brliPlan and execute quality activities independently to ensure subject safety and data integrity, complying with protocols and regulations. /li /brliLead compliance investigations and ensure timely closure of corrective and preventive actions from deviations, audits and inspections. /li /brliEscalate issues early and ensure effective resolution or measures are in place. /li /brliLead or contribute to complex projects. /li /brliManage pre‑inspection documentation and quality reviews in collaboration with functional SMEs and global process owners. /li /br /ul /brh3Performance Monitoring /h3 /brul /brliConduct analytics and qualitative assessments to identify trends. /li /brliMonitor quality deliverables from vendors and partners, sharing updates with internal functions. /li /brliEnsure continuous inspection readiness and integrity of data included in regulatory dossiers. /li /brliLead or support inspections and investigations, coordinating responses and hosting strategies. /li /br /ul /brh3GxP Quality Advisor Responsibilities /h3 /brul /brliReview and implement updates to GxP legislation, define best practices and assess impact on procedures, systems and contractual arrangements. /li /brliProvide expert advice to mitigate compliance risks or address complex issues. /li /brliDeliver presentations to peers, senior management, and industry audiences. /li /br /ul /brh3Qualifications /h3 /brul /brliBachelor's degree in a relevant scientific or healthcare‑related field. /li /brliMinimum of 10 years in the (bio)pharmaceutical industry, with at least 5 years in research or clinical development. /li /brliAt least 2 years of experience within the ATMP regulatory framework. /li /brliFluent in English communication (oral and written); additional languages are a plus. /li /brliProven track record of contributing to gene therapy clinical programs with technical and scientific expertise. /li /brliAbility to translate regulatory and quality expectations into operations, based on knowledge of quality principles. /li /brliExperience in GLP, GCP and/or GVP quality auditing, inspection, compliance management, and/or Medical Device regulations/operations is an asset. /li /brliAbility to drive collaboration and engagement across the stakeholder network, motivating others to achieve results. /li /brliSkilled in influencing others within a global matrix organization and driving informed decision‑making. /li /brliCapable of prioritizing and focusing on critical issues using a risk‑based approach. /li /brliManages quality and compliance issues with diligence, rigor, transparency and timeliness. /li /brliStrong analytical skills with experience in analyzing and synthesizing complex data. /li /brliProficient in presenting complex projects and issues clearly and succinctly. /li /br /ul /brpUCB 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 /p /p #J-18808-Ljbffr