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.

This is a hands-on leadership position with full autonomy. 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. You will have the autonomy to identify gaps, initiate corrective work, and follow it through to verified completion.

Your responsibilities

• Own the QMS end to end. Lead its operation, maintenance, and continuous improvement, including the quality manual, procedures, controlled records, review schedules, training, and management review.



Ensure procedures reflect presente practice and that each process has clear responsibilities and evidence of execution.

• 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.

• Own validation and the maintenance of the validated state. Maintain traceability between int

📌 Head of Quality (Barcelona)
🏢 Vigintake
📍 Barcelona