Galapagos – QMS Backlog Reduction and System Transition
Overview
Galapagos, a biopharmaceutical company, engaged Progress to support its EU Manufacturing division during a transition period. A shutdown of the one QMS system was required, while backlog items across functions had accumulated due to resource constraints. We were brought in to facilitate both the shutdown planning and backlog reduction, whilst advising on process governance and structural improvements.
Objective
The objective was to coordinate the manufacturing SMEs in executing the controlled shutdown and transfer of the SciLife QMS system and significantly reduce the existing backlog of quality records. I was responsible for identifying key bottlenecks, aligning internal stakeholders and external suppliers, and implementing targeted interventions. The assignment also required preparation for upcoming audits, where demonstrable backlog reduction and a clear improvement strategy were key to showing organizational commitment. In parallel, I advised on governance improvements and restructuring to ensure long-term process stability.
Key Challenges & Approach
The main challenge was the scope and complexity of the backlog which spanned multiple departments and suppliers. Many issues lacked clear ownership and existing governance structures were not equipped to prioritize or escalate effectively. Additionally, audit pressure required demonstrable progress within short timelines.
I began by mapping the backlog across systems and functions, identifying clusters of recurring issues and critical gaps in process accountability. I engaged cross-departmental stakeholders in weekly alignment sessions and introduced a tracking system to create transparency and momentum.
A key intervention was the launch of a daily triage process, where open deviations and potential CAPAs were discussed proactively. This clarified responsibilities upfront and significantly reduced the need for rework or lengthy discussions later in the process. Combined with targeted governance proposals, this approach enabled the teams to focus, reduce complexity, and regain control of both backlog and QMS transition activities.
Execution
I integrated into the organization’s operational and quality governance structures; working closely with key stakeholders across Quality, Manufacturing, and other departments. I facilitated coordination between internal teams and third-party suppliers to align priorities and ensure backlog items progressed efficiently. I designed a strategy and managed the endorsement and execution for a creative approach to compliantly transfer documents to the new system in a lean manner by bracketing similar issues. I lead the coaching of the team in implementing the improvements to avoid high backlog in future. Additionally, I supported audit preparation by ensuring traceability of backlog reduction efforts. This hands-on, structured coordination enabled steady progress in a complex and dynamic environment.
Conclusion & Lessons Learned
The assignment at Galapagos resulted in a substantial reduction of the SciLife QMS backlog and introduced a structured approach to quality governance. The daily triage and visual monitoring tools improved cross-functional alignment and built momentum toward closure of key items. Audit preparations were strengthened by improved documentation and traceability, which contributed to positive outcomes during inspections.
The project also supported the strategic phase-out of the SciLife QMS, which was successfully decommissioned in favor of a transition to Veeva. In the process, underlying gaps in ownership and governance were uncovered, of which I proactively lead the resolution.
This case highlights how establishing a root cause, focused interventions, clear roles and ownership, and disciplined follow-up can help organizations shift from reactive backlog handling toward a more proactive and sustainable quality system framework.
