Quality Documentation Specialist | GMP Biotech / Manufacturing EnvironmentCompany DescriptionA leading biotechnology company operating in a dynamic, fast-paced cGMP-regulated environment is seeking a Quality Documentation Specialist to join its Quality organization. This role focuses on documentation management, archiving, user support, and continuous improvement of Quality Systems. The position is key to ensuring regulatory compliance, operational efficiency, and robust documentation processes aligned with FDA and GMP standards.Job DescriptionAs a Quality Documentation Specialist, you will manage documentation systems, archiving, and user support within the Quality organization. You'll act as system or process owner, train end-users, support audits and inspections, and drive continuous improvement initiatives.You will play a crucial role in ensuring compliance with internal procedures and regulatory requirements, supporting cross-functional teams, and contributing to the site's overall quality and compliance culture.Key ResponsibilitiesSystem Ownership & User SupportAct as System/Process Owner or Administrator for assigned process(es)/system(s).Maintain the Documentation Quality System, including archiving activities.Assist and train end-users on processes, systems, and issue resolution.Manage user account requests and training toolkits.Create, update, approve, and archive controlled documents.Escalate and communicate critical issues when required.Maintain and update the team's SharePoint.Continuous Improvement & Site InitiativesCollaborate with business partners locally, at other sites, and globally to implement system improvements.Support business partners in expressing requirements and propose adapted solutions.Act as Quality Representative in routine and project activities to support regulatory compliance.Support site initiatives and continuous improvement projects.ComplianceSupport regulatory inspections, internal audits, and closure of observations/audit items.Support preparation of local, Biologics Operating Unit, and Global Quality Councils.Support Gemba walks in GxP and non-GxP areas.Coordinate collection of site Quality Metrics/KPIs.Provide back-up support for other Quality Systems as assigned.Essential RequirementsDegree in pharmaceutical sciences, life sciences, or related scientific discipline.Minimum 2 years of (bio)pharmaceutical industry experience, ideally in a multinational environment.Knowledge of GMP and regulatory guidelines (US-FDA, EMA, ICH).Understanding of Good Data and Documentation Practices (GDDP) and Data Integrity principles.Knowledge of document version control, workflows, and archiving.Awareness of audit and inspection readiness requirements.Language & IT SkillsProficiency in electronic document management systems (e.g., Veeva Vault).Proficiency in French and English (minimum B2 level).Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, SharePoint).CompetenciesStrong written and verbal communication skills.Ability to work cross-functionally (quality, manufacturing, supply chain).Strong organizational skills with ability to manage multiple priorities.Analytical mindset and ability to simplify complex issues.Meticulous adherence to regulatory standards.Continuous improvement mindset and ability to drive change.Skilled in training, troubleshooting, and identifying gaps in quality systems.Additional InsightsLocation: Neuchâtel, SwitzerlandDepartment: Quality Systems / DocumentationStart Date: ASAPInterested?Please send your CV to Miguel Gomes atm.-or reach out directly at .