Quality Manager (GxP / Distribution and Quality Europe)

Description du poste

* Prestigious biotech company * Temporary 12 month contract with option to extend or go permanent. ## About Our Client ## Prestigious biotech company ## Job Description ## * Provide 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 * Take ownership of quality issues and drive them to full resolution in close collaboration with Supply Chain, Manufacturing, Clinical Operations, Regulatory Affairs, and other stakeholders * Monitor and manage temperature excursions, deviations, and complaints in a timely and compliant manner * Act as Subject Matter Expert (SME) for deviation management and change control processes * Analyze and resolve quality and operational process anomalies, providing compliant and pragmatic solutions aligned with global and EU requirements * Support audits and inspections and contribute to regulatory submissions as required * Collaborate cross-functionally to develop, implement, and maintain policies, procedures, and SOPs * Work closely with EU Qualified Persons to ensure compliance with applicable European regulations and directives * Coordinate and manage Management Review activities, including data collection, KPI analysis, stakeholder alignment, and follow-up on actions and improvements * Lead and manage Quality Agreements with internal and external partners, ensuring alignment with GMP, GDP/GSP, and applicable legal requirements, including Swiss regulations * Collaborate closely with the Swiss Responsible Person and Deputy to ensure compliance with Swiss regulatory requirements * Monitor performance metrics and provide regular updates to management, including escalation of risks and challenges * Develop and support training materials and programs related to quality processes and standards * Contribute to continuous improvement initiatives across Quality and Supply Chain functions * Perform additional duties as assigned ## The Successful Applicant ## * Bachelor's degree in a scientific discipline or an equivalent combination of education and relevant work experience * 3-6 years of experience in the pharmaceutical or biotechnology industry * Experience working with Investigational Medicinal Products (IMPs) * Strong knowledge of GMP and GDP, ideally within a drug development environment * Experience in quality functions and cross-functional collaboration with manufacturing and supply chain teams * Understanding of global and local GCP regulations is an advantage * Experience working with external partners such as CMOs is preferred * Strong analytical and problem-solving skills with the ability to manage complex quality issues * Excellent communication and stakeholder management skills * Proactive, detail-oriented, and able to manage multiple priorities in a dynamic environment * Strong sense of ownership, accountability, and collaboration ## What's on Offer ## Interested to take you next step within quality? Happy to review your application. Quote job ref JN-062026-7031509 Job Function Healthcare & Life Sciences Specialisation Biotechnology Industry Healthcare / Pharmaceutical Location Basel Contract Type Interim Job Reference JN-062026-7031509 Job Nature Home Office