Jobs at WEP Clinical

Leads regional and global Post Approval Named Patient Programs and related clinical research projects, managing timelines, budgets, teams, client relationships, risks, training, quality, documentation, and regulatory compliance. Oversees eTMF and CTMS activities, site operations, payments, SOP adherence, change orders, and project delivery. Requires French fluency, clinical research or PA-NPP experience, knowledge of ICH GCP and clinical development, strong organizational and communication skills, and proficiency with Microsoft Office and clinical systems.

Lead Clinical Quality Assurance for GCP QMS across global clinical operations and decentralized trials. Oversee QA team, audits/inspections, investigations, CAPAs, vendor oversight, QMS records, quality metrics, and continuous improvement while ensuring regulatory compliance and inspection readiness.

Oversee compliance with EU Good Distribution Practice, national regulations, and wholesaler authorization requirements. Maintain the quality management system, approve GDP procedures and changes, oversee deviations and CAPAs, manage training, recalls, complaints, supplier and customer approvals, subcontracted activities, and self-inspections. Decide on product disposition and ensure accurate records and regulatory compliance. The role may also serve as Deputy Responsible Person for the UK and provide line management.

Lead site QA for GMP/GDP manufacturing and distribution, overseeing quality operations, deviations, CAPAs, inspections, secondary packaging, warehouse controls, and a QA team. Drive QMS improvements, regulatory compliance, risk-based decisions, and cross-functional stakeholder engagement to protect patient safety and product quality.

Lead and execute cGMP secondary packaging and labeling operations, ensuring audit-ready batch execution, accurate MBR/EBR documentation, label/artwork control, ERP BOM maintenance, vendor coordination, regulatory alignment, and process improvement across global supply chain operations.

Lead global regulatory strategy and operational oversight for Expanded Access, Open Label Extension, and Post-Approval Named Patient Programs. Provide regulatory guidance across US, EU, UK, and other regions; maintain US licenses; engage regulatory authorities; support internal projects and client proposals; and manage, train, and develop Regulatory Affairs staff.

Lead on-site and remote clinical monitoring to ensure protocol, ICH-GCP, and regulatory compliance. Manage site selection, initiation, routine and close-out visits; verify source data and CRFs; review safety and IP accountability; resolve queries and drive CAPAs; train and mentor CRAs; act as primary monitoring contact for sponsors and project teams.