About this role
Project Manager | Amsterdam | Gene Therapy | BLA/MAA | Quality & Supply Chain Readiness Your new company Your new company is based in the Amsterdam area and is focused on developing innovative gene therapy treatments for patients with serious unmet medical needs. As the company moves through regulatory review and prepares for commercial launch, they are seeking an experienced Project Manager to drive cross-functional execution across Regulatory, Quality, CMC, and Supply Chain teams. Your new role The Project Manager is responsible for coordinating and driving project execution during regulatory review and launch readiness activities. The role focuses on ensuring accountability, tracking deliverables, managing risks and dependencies, and maintaining alignment across multiple stakeholders without direct line management authority. The successful candidate will support activities spanning CMC regulatory review, Global Quality launch readiness, and Commercial Supply Chain readiness. Responsibilities - Track and coordinate CMC activities supporting BLA and MAA regulatory review processes. - Monitor progress of regulatory Q&A responses and escalate potential delays. - Organize meetings, track actions, and ensure closure of regulatory review activities. - Maintain and manage quality launch readiness trackers, including change controls, deviations, CAPAs, and inspection readiness activities. - Track commercial launch lots, specification updates, labeling changes, batch record updates, and related documentation. - Build and maintain an integrated global launch plan covering Regulatory, Quality, CMC, and Supply Chain workstreams. - Manage project risks, actions, issues, and decisions through RAID logs and contingency planning. - Track critical path activities, dependencies, and vendor deliverables to ensure launch timelines are achieved. - Support go/no-go launch readiness reviews through accurate status reporting and dashboard manage...