Assurance Quality Expert - Computerized Systems Cs - Qrm H/F - 78

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.Excelya: Your Future Starts Here

At Excelya, we pride ourselves on being a leading mid-size Contract Research Organization (CRO) with over 900 passionate professionals dedicated to improving healthcare. Our core values of Audacity, Care, and Energy guide our actions and decisions as we work collaboratively to drive innovation in clinical research.

Position Overview:

We are currently looking for a knowledgeable and detail-oriented Quality Assurance Expert specializing in Computerized Systems (CS/QRM) to join our dynamic quality assurance team. In this role, you will be instrumental in ensuring the compliance, quality, and effectiveness of our computerized systems and the associated quality risk management processes.

Main Responsibilities:

- Ensure compliance and validation of Computerized Systems in alignment with GxP requirements and internal guidelines
- Define and implement risk-based validation strategies based on system criticality (data integrity, patient safety, product quality)
- Review existing validation documentation and oversee proper management of deviations or issues
- Supervise outsourced validation activities, including deliverables review, KPIs monitoring, and adherence to internal procedures
- Support validation activities across Agile and V-model lifecycle projects
- Provide guidance and expertise to teams on Computerized System Validation best practices
- Deliver training sessions to internal stakeholders on validation principles and compliance expectations
- Conduct initial and periodic risk assessments of computerized systems
- Participate in audits, supplier assessments, and provide input during regulatory inspections
- Contribute to the implementation and follow-up of corrective and preventive actions (CAPA)
- Monitor regulatory evolution and assess impacts on CSV processes and documentation