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 vigente 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 intended use, requirements, risks, tests, and results. Ensure evidence identifies the exact software build, configuration, environment, and dataset tested. Preserve failures, deviations, retests, and limitations, and assess when changes require additional validation.
- 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 authority where independent. Ensure release decisions and post‑deployment verification remain traceable.
- Own non‑conformances, complaints, and CAPA processes. Ensure appropriate containment, root‑cause investigation, corrective and preventive actions, effectiveness checks, and independent closure. Identify recurring issues and drive improvements across the business

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- Maintain controlled documentation. Manage document review, approval, versioning, effective use, retention, and retirement. Coordinate role‑based training and verify that personnel understand and can perform their quality responsibilities.
- Lead supplier, customer and operational quality assurance. Own supplier qualification and periodic review, including cloud, AI, and QMS tooling. Work with technical and business owners to verify controls for access, auditability, retention, backup restoration, disaster recovery, privacy, and continuity.
- Lead AI quality oversight. Assess changes to models, prompts, providers, and extraction workflows. Define representative evaluations, investigate incorrect or missed outputs, assess variability and human oversight, and coordinate periodic revalidation.
- Lead audit readiness and quality reporting. Coordinate internal audits and customer quality assessments, maintain retrievable evidence, and drive findings to closure. Present management with a clear view of validation status, open risks, overdue actions, supplier issues, and QMS effectiveness. Monitor relevant changes in regulatory expectations and translate applicable requirements into practical controls.

Authority and working relationships

You will own the quality agenda and have direct access to the CEO for escalation.

You will be empowered to require additional assessment or testing and to withhold quality approval when acceptance criteria, evidence, or controls are inadequate.





You will work closely with Engineering and business process owners, holding them accountable for their quality responsibilities.

What you bring

- Demonstrated ownership of a QMS or substantial quality function within a SaaS business serving GxP regulated customers.
- Practical experience applying GAMP 5, computerized system validation, data‑integrity principles, and relevant electronic‑record requirements according to intended use.
- Experience writing or maintaining test scripts or automation and assessing automated test results alongside manual evidence.
- Understanding of cloud SaaS architecture, integrations, multi‑tenant systems, CI/CD, configuration management, and controlled releases.
- Proven experience evaluating risk assessments, managing CAPAs, controlling documents, qualifying suppliers, and supporting customer audits.
- The judgment to scale assurance activities to risk and explain why a control or test is sufficient.
- The autonomy to move from identifying a problem through investigation, action, verification, and closure.
- Clear written communication and the confidence to challenge technical and business decisions constructively.

Bonus Points

- You leverage AI tools to help you streamline your workflows; you are a heavy user of any AI harness to speed your workflow s?
- Technical testing capability: confident working with web applications, APIs, SQL queries, logs, structured data, and test environments.
- Experience with pharmacovigilance software, AI‑assisted workflows, Jira, Confluence, and electronic document‑approval systems would be particularly valuable.
- Prior systems/support/operations/qa at a pharmacovigilance company.
- Eudravigilance submissions experience. You have worked on a system that submits directly to EV gateway, in both XCOMP and Gateway.

What success looks like

Your first priorities will be to establish a verified picture of QMS and validation status, agree a prioritized improvement plan, and take operational ownership of reviews, training, risk decisions, and quality actions.

Over time, success means current and usable procedures, reproducible test evidence, timely and effective corrective actions, well‑supported release decisions, and a quality system that remains effective as Vigintake grows.

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📌 Head of Quality & GxP Assurance (Barcelona)
🏢 Vigintake
📍 Barcelona