Ph3About Our Client /h3 ul liPrestigious biotech company /li liTemporary 12 month contract with option to extend or go permanent. /li /ul h3Job Description /h3 ul liProvide quality oversight of internal and external GxP operations and lead, coordinate, and troubleshoot quality investigations, ensuring thorough root cause analysis and implementation of appropriate CAPAs /li liTake ownership of quality issues and drive them to full resolution in close collaboration with Supply Chain, Manufacturing, Clinical Operations, Regulatory Affairs, and other stakeholders /li liMonitor and manage temperature excursions, deviations, and complaints in a timely and compliant manner /li liAct as Subject Matter Expert (SME) for deviation management and change control processes /li liAnalyze and resolve quality and operational process anomalies, providing compliant and pragmatic solutions aligned with global and EU requirements /li liSupport audits and inspections and contribute to regulatory submissions as required /li liCollaborate cross-functionally to develop, implement, and maintain policies, procedures, and SOPs /li liWork closely with EU Qualified Persons to ensure compliance with applicable European regulations and directives /li liCoordinate and manage Management Review activities, including data collection, KPI analysis, stakeholder alignment, and follow-up on actions and improvements /li liLead and manage Quality Agreements with internal and external partners, ensuring alignment with GMP, GDP/GSP, and applicable legal requirements, including Swiss regulations /li liCollaborate closely with the Swiss Responsible Person and Deputy to ensure compliance with Swiss regulatory requirements /li liMonitor performance metrics and provide regular updates to management, including escalation of risks and challenges /li liDevelop and support training materials and programs related to quality processes and standards /li liContribute to continuous improvement initiatives across Quality and Supply Chain functions /li liPerform additional duties as assigned /li /ul h3The Successful Applicant /h3 ul liBachelor's degree in a scientific discipline or an equivalent combination of education and relevant work experience /li li3-6 years of experience in the pharmaceutical or biotechnology industry /li liExperience working with Investigational Medicinal Products (IMPs) /li liStrong knowledge of GMP and GDP, ideally within a drug development environment /li liExperience in quality functions and cross-functional collaboration with manufacturing and supply chain teams /li liUnderstanding of global and local GCP regulations is an advantage /li liExperience working with external partners such as CMOs is preferred /li liStrong analytical and problem-solving skills with the ability to manage complex quality issues /li liExcellent communication and stakeholder management skills /li liProactive, detail-oriented, and able to manage multiple priorities in a dynamic environment /li liStrong sense of ownership, accountability, and collaboration /li /ul h3What's on Offer /h3 pInterested to take you next step within quality? Happy to review your application. /p /p #J-18808-Ljbffr