Prepare, review, and implement Global Quality Management System (QMS) procedures across sites, ensuring alignment with regulatory expectations including US FDA, EMA, ICH, ANVISA, GLP, and 21 CFR Part 11.
Lead digital system implementation projects including LIMS, e-BMR/e-BPR, e-Logbook, and digital checklists. Provide routine project status updates to senior management and ensure timely execution.
Perform Computer System Validation (CSV) activities in accordance with GAMP 5. Prepare and maintain URS, FS, DS, IQ/OQ/PQ, traceability matrices, and validation reports. Ensure audit readiness and compliance with 21 CFR Part 11 and EU Annex 11.
Lead and support preparation, review, and approval of Global QMS procedures related to LIMS and digitization activities.
Demonstrate strong hands-on knowledge of Caliber LIMS, including module implementation, master data creation, review, and approval. Manage end-to-end LIMS implementation and configuration.
Collaborate with cross-functional teams (QC, QA, Manufacturing, IT) to ensure digital systems meet business and quality requirements. Support internal and external audits focused on digital and computerized systems.
Monitor system performance, manage change controls, ensure data integrity, and address system issues.
Provide training to LIMS users, maintain training records in MasterControl, and ensure timely training completion for the team.
Work closely with IT and site quality teams to integrate QMS processes into digital systems, enabling seamless compliance tracking.
Initiate, investigate, and close QMS elements including deviations, change controls, CAPA, and Laboratory Investigations. Ensure documentation accuracy and regulatory compliance.
Prepare, review, and maintain GMP documents and SOPs related to LIMS operations.
Track, monitor, and ensure timely achievement of departmental KPIs and alignment with organizational goals.
Experience Requirements -
10–15 years industry experience in pharmaceuticals/biologics.
Minimum 5 years digitization experience in regulated environments.
Strong understanding of CSV, GLP, 21 CFR Part 11, and QC testing.
Proven experience leading Caliber LIMS implementation projects.
