Evidence Quality Lead
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Make your mark for patients
To strengthen our Global Quality Assurance department, we are looking for a talented professional to fill the position of: Evidence Quality Lead – Braine l’Alleud, Belgium.
About the role
As part of the UCB Quality organization, the Evidence Quality Lead (EQL) actively enables compliant Research, Development and Pharmacovigilance processes (i.e., GLP GCP GVP) from candidate to asset delivery, to commercial branding, with a focus on successful global launches and sustainable access for our patients. Collaborating with internal teams and external stakeholders, the EQL plays a crucial role in ensuring quality by design and maintaining continuous inspection readiness.
You will work with
You will work closely with a variety of internal functions within Quality and the Business area’s you support. Additionally, you will engage with external partners and vendors to ensure the integrity of data for delegated activities.
What you will do
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 vendorsEnsure compliance with GxP regulations, guidance, and internal procedures while reducing complexityProactively Identify 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 regulationsLead compliance investigations and ensure timely closure of corrective and preventative actions from deviations, audits and inspectionsEscalate issues early and ensure effective resolution or measures are in placeLead or contribute to complex projectsManage pre-inspection documentation, quality reviews, in collaboration with functional SMEs and global process owners.Monitor Performance
Conduct analytics and qualitative assessments to identify trendsMonitor quality deliverables from vendors and partners, sharing updates with internal functionsEnsure continuous inspection readiness and integrity of the data included in regulatory dossiersLead/support inspections and investigations, coordinating responses and hosting strategiesGxP Quality Advisor Responsibilities
Review and implement updates to GxP legislation, define best practices and assess the impact on procedures, systems and contractual arrangementsProvide expert advice to mitigate compliance risks or to address complex issues.Deliver presentations to peers, senior management, and industry audiences
Interested? For this position you’ll need the following education, experience and skills
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
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