Senior QA Expert

Senior QA Expert for QC driving gLIMS implementation and GMP quality oversight within a complex pharmaceutical laboratory environment at Lonza. Senior QA Expert Job description: Work with a leading Life Sciences organisation on a key Quality Assurance project supporting QC Microbiology and the implementation of a new laboratory execution system. About the customer: Location: Stein, Aargau Start: ASAP / September 2026 Duration: Until 28 February 2027 Workload: 60% Language: Fluent English required; German is an advantage Requirements: Provide QA oversight and guidance to the Quality Control department, ensuring compliance with GMP requirements and internal procedures. Act as the primary QA point of contact for the implementation of gLIMS / Laboratory Information Management Systems (LIMS) . Support cross-functional growth projects and ensure QA/QC deliverables are completed according to agreed timelines. Review and approve GMP-relevant QC documentation, including SOPs related to the gLIMS implementation. Manage quality activities including change requests, deviations/non-conformities and document management. Write, revise and own SOPs within your area of expertise. Support QC raw data review where required. Ensure compliance with internal quality standards, regulatory GMP requirements and health authority guidance. Support inspections and audits and contribute to KPI management and reporting. Competences: 8+ years of experience supporting projects involving the implementation of laboratory execution systems within a quality-focused environment. Strong hands-on experience with gLIMS / LIMS implementation . Strong background in cGMP regulations and pharmaceutical Quality Assurance / Quality Control. Very good understanding of laboratory environments, equipment, software qualification and validation . Experience with Computer System Validation (CSV) is highly advantageous. Experience interacting with health authorities such as FDA and Swissmedic . Knowledge of US, European and Japanese Pharmacopoeia requirements. Structured, organised and solution-oriented approach with the ability to work effectively across functions. Fluent English; German is a plus. Project management or continuous improvement certification such as Green Belt / Black Belt is an advantage.