When a quality system isn't consistently followed or is creating friction rather than control, I assess how it actually functions — not just how it's documented — and identify the root causes behind recurring failures.
I held complete responsibility for the site's quality management systems, spanning manufacturing, quality control, shipping and receiving, and engineering and maintenance. After completing gap analyses, I implemented SOPs, policies, and quality systems, including change control and OOS investigation (deviation) and CAPA management, and monitored quality metrics for continuous improvement.
At contract manufacturing sites I implemented and monitored quality systems using Six Sigma processes, ran root cause analysis with 5M, 5 Whys, and fishbone (Ishikawa) tools, and presented quality trending to senior management on a regular basis.
I initiated and implemented the change control program and put vendor quality and service agreements in place to make them cGMP compliant, while overseeing quality control and R&D for the full product line.
A quality system your organization can actually run on, not just point to.