Job speichern Zurück zu Suche Stellenbeschreibung Übersicht Ähnliche Jobs hinzugefügt 03/06/2026Prestigious biotech companyTemporary 12 month contract with option to extend or go permanent.FirmenprofilPrestigious biotech companyStellenbeschreibungProvide quality oversight of internal and external GxP operations and lead, coordinate, and troubleshoot quality investigations, ensuring thorough root cause analysis and implementation of appropriate CAPAsTake ownership of quality issues and drive them to full resolution in close collaboration with Supply Chain, Manufacturing, Clinical Operations, Regulatory Affairs, and other stakeholdersMonitor and manage temperature excursions, deviations, and complaints in a timely and compliant mannerAct as Subject Matter Expert (SME) for deviation management and change control processesAnalyze and resolve quality and operational process anomalies, providing compliant and pragmatic solutions aligned with global and EU requirementsSupport audits and inspections and contribute to regulatory submissions as requiredCollaborate cross-functionally to develop, implement, and maintain policies, procedures, and SOPsWork closely with EU Qualified Persons to ensure compliance with applicable European regulations and directivesCoordinate and manage Management Review activities, including data collection, KPI analysis, stakeholder alignment, and follow-up on actions and improvementsLead and manage Quality Agreements with internal and external partners, ensuring alignment with GMP, GDP/GSP, and applicable legal requirements, including Swiss regulationsCollaborate closely with the Swiss Responsible Person and Deputy to ensure compliance with Swiss regulatory requirementsMonitor performance metrics and provide regular updates to management, including escalation of risks and challengesDevelop and support training materials and programs related to quality processes and standardsContribute to continuous improvement initiatives across Quality and Supply Chain functionsPerform additional duties as assignedAnforderungsprofilBachelor's degree in a scientific discipline or an equivalent combination of education and relevant work experience3-6 years of experience in the pharmaceutical or biotechnology industryExperience working with Investigational Medicinal Products (IMPs)Strong knowledge of GMP and GDP, ideally within a drug development environmentExperience in quality functions and cross-functional collaboration with manufacturing and supply chain teamsUnderstanding of global and local GCP regulations is an advantageExperience working with external partners such as CMOs is preferredStrong analytical and problem-solving skills with the ability to manage complex quality issuesExcellent communication and stakeholder management skillsProactive, detail-oriented, and able to manage multiple priorities in a dynamic environmentStrong sense of ownership, accountability, and collaborationSonstige InformationenInterested to take you next step within quality?Happy to review your application.Referenznummer angebenJN-062026-7031509ZusammenfassungBerufsfeldHealthcare & Life SciencesNäheres BerufsfeldBiotechnologieBrancheHealthcare / PharmaceuticalOrtBaselVertragsartInterimReferenznummerJN-062026-7031509Art des JobsHome Office
