Quality Manager
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Description du poste
# Quality Manager # (m/f/d) Freelance/temporary employment for a project Basel Stadt Start date: asap Reference number: 881691/1 ### Responsibilities ### * Regulatory Compliance: Act as the appointed Delegate of the Swiss Responsible Person (FvP), providing necessary final Quality decision-making * Global Oversight: Maintain Global QA oversight for the entire IMP Distribution Network and its business counterparter PTDS-L * Lead the Deviation Management process by performing product quality impact assessments. Provide crucial Quality oversight by reviewing and assessing final evaluations and statements from third parties, ensuring consistency with regulatory standards, and checking if proposed Corrective and Preventive Actions (CAPA) are appropriate * System Owner: Manage the full lifecycle of quality documentation and Change Records, including establishing, reviewing, and approving critical documents and changes for both internal procedures and external business documents (PTDS-L) * Inspection Management: Actively drive and support all GxP inspections and audits * Quality Decision-Making: Manage Temperature Excursion Management for clinical trials, including performing assessments and managing Expert Statements/Opinions * Support clinical studies by reviewing and approving IMP Supply & Release Flowcharts, Transfer requests, and Expert Opinions * Establish and approve Master Quality Agreements and Quality Agreements * Manage Complaint Management for clinical trials within the network * Support quality-related and business-driven projects within the IMP Distribution network ### Profile ### * A Bachelor's degree in a relevant scientific or technical field (e.g., Pharmacy, Chemistry, Biology, Engineering) * Proven and comprehensive experience in Quality Assurance with a strong focus on compliance * Deep knowledge of a regulated GxP environment (GMP/GDP) * Fluent spoken and written English; German is a plus. Fluency is essential for managing critical regulatory documentation, providing authoritative guidance to European sites, and ensuring successful support during Health Authority Inspections * Familiarity with Veeva vault QMS * PTQ experience * Experience in supplier management, especially depots ### Benefits ### * Fascinating, innovative environment in an international atmosphere * Extension: very likely
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