KAYENTIS

1 Job

167 Employees

About the Company

Kayentis, a global leader in eCOA and decentralized clinical trial solutions, empowers pharma, biotech and CROs to streamline data collection in clinical trials, enhancing simplicity, efficiency and data quality. Since 2005, Kayentis has spearheaded clinical development, specializing in eCOA solutions across phases I-IV in over 200 indications across more than 20 therapeutic areas. Adapting to the changing landscape, Kayentis is now offering a comprehensive suite of services to support science-driven and patient-centric clinical research, with operational capabilities across the US, Europe and Asia.

Listed Jobs

Company Name: KAYENTIS
Job Title: Ingénieur Qualité Logicielle & Gestion des Risques (H/F)
Job Description: **Job title** Software Quality & Risk Management Engineer **Role Summary** Ensure the quality, reliability, and regulatory compliance of Kayentis clinical investigation software. Lead risk management, validation, and process improvement activities across design, development, and IT interfaces while maintaining compliance with GAMP 5, ISO 14971, and 21 CFR Part 11. **Expectations** - Apply regulatory standards to all software and IT processes. - Maintain and enhance quality and risk‑management frameworks. - Train and support cross‑functional teams in quality systems. - Collaborate with internal and external auditors, suppliers, and contractors. **Key Responsibilities** - Maintain and continuously improve the Validation Master Plan and associated documentation. - Review development deliverables for quality compliance before production release. - Update and enforce risk‑management and validation processes in alignment with ISO 14971. - Conduct internal and client audits, including supplier qualification and subcontractor audits. - Validate computerized systems and ensure adherence to 21 CFR Part 11 electronic signature and record requirements. - Provide training on the QA management system and applicable regulatory requirements. **Required Skills** - 5+ years in life sciences or medtech, with deep knowledge of software quality and risk management. - Expertise in ISPE GAMP 5, ISO 14971, and 21 CFR Part 11 (or equivalent). - Strong documentation, audit, and validation skills. - Bilingual: fluent English and French. - Collaborative, client‑focused communication. **Required Education & Certifications** - Master’s degree (or equivalent) in Quality Management, Risk Management, Software Engineering, or a related field. - Certifications in GAMP 5, ISO 14971, or 21 CFR Part 11 are a plus.