Thanks for joining me!

Start with what is right rather than what is acceptable. — Franz Kafka

Let me introduce myself. I am a quality manager in the pharmaceutical industry who for the last year has been doing quality systems deployment, and previous to that spent 4 years running the change management/change control program at a site under a consent decree with the FDA. I’ve spent almost two decades developing, implementing, and maintaining quality systems in biopharma. I an a senior member of the American Society of Quality with my Certified Manager of Quality/Operational Excellence (CMQ/OE) and Pharmaceutical GMP Professional certifications. I’ve been known to haunt one or three other professional associations.

This blog is my attempt to explore what I’ve learned. It is a example of thinking out loud. Perhaps, in that, it will be valuable to others.

The views and opinions expressed in this blog are those of the individual blogger (Jeremiah Genest) and should not be attributed to any company with which the blogger is now or has been employed or affiliated.