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.