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Quality lead (gcp)

Zoersel
2 Bridge
Publiée le 21 janvier
Description de l'offre

Overview2 Bridge is a Belgian-based consultancy supporting healthcare innovators across the full product development lifecycle: from discovery and preclinical development to clinical development, registration and life cycle management. We work globally with biotech, medtech, pharma companies and investors, often in complex and fast evolving development environments. Our teams are flexible, cross functional and tailored to project needs. Quality is a core pillar of our approach — not as a control mechanism, but as a strategic enabler for development success.Your roleAs Quality Lead, you take end-to-end responsibility for quality strategy and execution across multiple client projects and programs, with a strong focus on GxP-regulated early clinical development. You operate at the program level, working closely with senior client stakeholders and multidisciplinary teams. You translate regulatory requirements into pragmatic, risk-based quality solutions that support development progress while ensuring sustainable compliance.This is a hybrid role with maximum flexibility depending on client needs.What you will doOwn and drive quality strategy, scope and delivery across multiple GxP programsAct as program-level quality lead, aligning quality objectives with development strategy, timelines and resourcesDesign, implement and continuously improve Quality Management Systems (QMS) in regulated GxP environmentsLead risk management activities, investigations, CAPAs and audit readinessSupport eQMS implementations and broader quality transformation initiativesAct as a trusted quality partner to senior management and C-level stakeholdersLead and coach teams through expertise and influenceWho we are looking forMSc or PhD in Pharmacy, Biomedical Sciences, Bio-engineering or a related field~10 years (or more) experience in GCP quality managementSolid understanding of clinical development processes and regulatory frameworks (GxP, ICH, etc.)Experience with audits and inspectionsStrategic, analytical, and pragmatic mindsetStrong communicator, comfortable at the senior and executive levelHigh autonomy & trust in a collaborative, value driven environment.Exposure to diverse clients, technologies and development stagesReal impact: you shape quality strategies in complex, high-value development programs and you have the opportunity to actively contribute to the growth and direction of our quality practice2 Bridge offers a competitive salary package with attractive extralegal benefits, including company car.Interested?Visit our website www.2bridge.beSend your CV and motivation to hr@2bridge.be
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