Digital Quality, IT Project Quality Manager - LIMS
Core
Ensure qualification and validation compliance of computerized systems (LIMS, MES) for cGMP activities, driving planning and execution of validation deliverables to maintain data integrity and regulatory standards.
Role type
IT Project Quality Manager (CSV)
Builds
Validated computerized systems for pharmaceutical manufacturing and testing
Domain
Pharmaceutical industry / Computer Systems Validation (CSV)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer Systems Validation (CSV), Laboratory Information Management Systems (LIMS), GxP, GAMP 5, 21 CFR Part 11, Test Management Systems, Project Management, Risk Assessment, Technical Documentation Review, Regulatory Compliance (FDA, Swissmedic), Data Integrity
Preferred skills
MES implementation, Global Capability Center (GCC) experience, Cross-functional team leadership
Technologies
LIMS, Kneat (Test Management System), QMS
Responsibilities
Create and maintain validation execution plans aligned with project timelines and budgets; Lead planning and execution of validation deliverables for LIMS and other computerized systems; Manage setup and execution of tests within the Test Management System; Act as the voice of Quality in cross-functional teams driving CSV strategy; Review and approve technical documentation, risk assessments, CSV protocols, reports, test scripts, and deviations; Ensure project team training according to IT requirements; Provide CSV guidance and translate regulatory trends into quality improvement projects; Support internal audits and regulatory inspections; Uphold and improve data integrity processes
Seniority
Mid-to-Senior, hands-on IC