Senior leadership teams hold the ultimate responsibility for an effective Pharmaceutical Quality System. Yet across the industry, PQS failures remain one of the most consistent findings in regulatory inspections. Why?
In this concise breakdown, NSF looks at the underlying causes of SLT underperformance on the PQS, including:
- limited understanding of PQS purpose and expectations
- weak engagement in Quality Management Review and oversight
- misalignment between quality and other site functions
- cultural barriers that prevent ownership, accountability and challenge
- quality teams failing to communicate value clearly to non-quality leaders
These issues directly contribute to major and critical deficiencies, hinder continuous improvement and create unnecessary risk for patient safety and site compliance.
If your organisation struggles with PQS engagement or leadership visibility, this video provides a clear starting point for understanding the gap and how to close it.
