Poor Quality Leadership from Senior Management.

This week, I will address the sixth of nine common CGMP Quality System shortcomings; Poor Quality Leadership from Senior Management.

I strongly believe that a strong quality environment is cultivated from the very highest levels of management. If senior management cares about quality implementation, then all levels of the company tend to buy into “quality matters”.

Inversely, if senior management doesn’t fully appreciate the direct connection between quality management and the bottom line, then a sub-robust quality system is likely to materialize.

A Quality Director isn’t likely to successfully implement a Robust Pharmaceutical Quality System, if Senior Management views the quality function as simple overhead. That Quality Director is likely to meet resistance at every turn and not receive the resources necessary to establish and maintain a health and effective quality system.

Unfortunately, it is unlikely the Quality Director will have the necessary influence to correct Senior Management’s quality short-sightedness, but it probably is worth an attempt. If all else fails, then it is probably best to search out a new corporate quality culture.