Senior eCompliance Specialist

Motum Technologies; Barcelona; On-site; EUR 60,000 - 90,000; Full time

Job summary

Motum Technologies seeks a Quality Assurance professional to provide oversight for GxP computerized systems across their lifecycle, from validation to daily operations. You will be the CSV liaison between IT and business teams, promoting a culture of quality.

The role emphasizes review and approval of validation deliverables, CAPA-driven improvements, and participation in VMP and supplier qualification activities, with a focus on AI-enabled eCompliance solutions.

Qualifications

• Degree in IT, Life Sciences, Pharmacy, Engineering or equivalent.
• At least 5 years of overall professional experience, including 4 years in pharma in regulated IT quality & compliance.
• Strong understanding of CSV, GxP and 21 CFR Part 11.
• Experience implementing, lifecycle managing and operating GxP computerized systems.
• Professional fluency in English.

Responsibilities

• Review and approve GxP applicability assessments and key validation deliverables.
• Review and approve GxP-impacting changes and deviations, ensuring CAPAs are implemented.
• Review and approve Periodic Review Reports and address identified gaps via CAPA management.
• Contribute to the Validation Master Plan (VMP) preparation and execution.
• 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.

Skills

Quality Assurance

CSV

GxP

Documentation

English fluency

CAPA management

Audits & Compliance

Education

IT/Life Sciences/Pharmacy/Engineering degree

Job description

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.