Vigintake is a SaaS platform supporting pharmacovigilance workflows, including intake, literature monitoring, case management, data extraction, and regulatory reporting. We are looking for a quality leader to take full ownership of our Quality Management System and the processes that sustain it.
You will be accountable for keeping the QMS current, effective, and aligned with applicable GxP expectations, customer requirements, and the way our software is developed and operated.
You will set quality priorities, maintain and improve procedures, evaluate risk assessments, design and execute tests, investigate quality issues, and ensure that decisions are supported by reliable evidence. Lead its operation, maintenance, and continuous improvement, including the quality manual, procedures, controlled records, review schedules, training, and management review. Lead GxP risk management. Prepare, review, and challenge assessments across software changes, data integrity, AI, suppliers, security, and service continuity. Evaluate credible harm, demonstrated controls, and residual risk,



and determine proportionate testing and escalation. Make clear, defensible quality decisions.
Independently design and execute technical testing. Translate requirements and risks into meaningful acceptance criteria, validation protocols, and functional, negative, integration, and regression tests. Reproduce defects, examine API responses, logs, audit trails, and data flows, and assess whether the system behaves correctly under normal and failure conditions.
Maintain traceability between intended use, requirements, risks, tests, and results. Ensure evidence identifies the exact software build, configuration, environment, and dataset tested. Lead quality oversight of changes and releases. Work with Engineering throughout assessment, development, testing, and deployment. Challenge incomplete evidence or unsupported risk conclusions, require corrective action, and exercise delegated quality approval a

📌 Quality Assurance Officer (Cataluña)
🏢 Vigintake
📍 Cataluña