Excelya

About the Company

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 compassion, care, and excellence.

Founded in 2014 and headquartered in Paris, France, and operating in 28 countries across Europe, USA and India, 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, with speciality focus on Oncology & Hematology, Rare Disease & Pediatrics, Infectious Disease, Inflammation & Immunotherapy, Pain Treatment & CNS, and Late Phase & RWE.

Listed Jobs

Company Name

Excelya

Job Title

Assurance Quality Expert - Computerized Systems (CS/QRM)

Job Description

Job Title: Assurance Quality Expert – Computerized Systems (CS/QRM) Role Summary Quality Assurance Expert responsible for validating and ensuring compliance of computerized systems in a regulated pharmaceutical/biotech environment, aligning with GxP requirements and supporting risk‑based validation strategies across development and maintenance lifecycles. Expectations - Maintain and enhance CS validation and risk‑management processes. - Provide expertise, training, and guidance on CS validation best practices. - Ensure CS reliability, data integrity, and regulatory compliance. Key Responsibilities - Validate computerized systems to meet GxP (GCP, GVP, GCLP, GLP, GMP) requirements. - Design and implement risk‑based validation plans based on system criticality. - Review and manage validation documentation, deviations, and issues. - Supervise outsourced validation activities, reviewing deliverables and monitoring KPIs. - Support validation across Agile and V‑model projects. - Conduct initial and periodic risk assessments of CS. - Participate in audits, supplier assessments, and regulatory inspections; provide inputs and support CAPA actions. - Monitor regulatory changes impacting CS validation and documentation. Required Skills - Strong knowledge of GxP regulations and CS validation. - Proven experience in CS risk‑based validation in a regulated setting. - Ability to conduct risk assessments, audits, and CAPA follow‑up. - Excellent communication; deliver training and guidance to stakeholders. - Bilingual proficiency in English and French. Required Education & Certifications - Bachelor’s degree in Life Sciences, Computer Science, or related field.

Saclay, France

Hybrid

12-02-2026