Your mission

Provide Quality Assurance oversight and guidance for GxP computerized systems, ensuring compliance throughout their lifecycle—from implementation and validation projects to day-to-day operations.

You will serve as a key point of contact for Computerized Systems Validation (CSV) and act as the interface between IT and business teams on eCompliance matters, promoting a culture of quality.

Your key responsibilities:

- Review and approve GxP applicability assessments and key validation deliverables.

- Review and approve GxP-impacting changes and deviations, ensuring appropriate CAPAs are implemented.

- Review and approve Periodic Review Reports and ensure identified gaps are addressed through the CAPA management system.

- Contribute to the preparation and execution of the Validation Master Plan (VMP).

- Participate in GxP supplier qualification activities and provide Quality support for audits and resulting actions.

- Advise project and operations teams on CSV and compliance requirements.

- Support the implementation, operation and optimization of automation and AI-enabled solutions for eCompliance activities.

What we’re looking for:

- A degree in Information Technology, Life Sciences, Pharmacy,



Engineering or an equivalent field.

- At least 5 years of overall professional experience , with additional experience preferred, including a minimum of 4 years of relevant pharmaceutical industry experience in regulated functions such as IT Quality & Compliance.

- A strong understanding of CSV, GxP and 21 CFR Part 11 , as well as Health Authority expectations.

- Experience in the implementation, lifecycle management and day-to-day operation of GxP computerized systems and their supporting technologies.

- Professional fluency in English , enabling you to work independently, contribute to meetings, review technical documentation and coordinate with international teams.

We’d also value:

- Knowledge of ITIL/ITSM and experience with systems supporting pharmaceutical development, manufacturing, quality, commercial operations or infrastructure.

- The ability to build trusted partnerships and influence without hierarchical authority.

- A proactive approach to driving initiatives and managing shifting priorities.

- Strong communication, negotiation and presentation skills, including engagement with management.

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📌 Senior eCompliance Specialist (Barcelona)
🏢 Motum Technologies
📍 Barcelona