Quality & Inspection Readiness: A Daily Commitment To Excellence

By Amanda Miccio, Associate Director. Quality Operations and Program Management

Quality problems at the CDMO level can mean costly delays or outright rejection, whether a product is on the market or awaiting approval. Amanda Miccio, Associate Director of Quality Operations and Program Management, who has led self-inspections and has over 15 years of experience in quality operations, argues that readiness is a steady state rather than a ramp-up before an audit. She considers how internal assessments can serve continuous improvement instead of a compliance exercise, what routine GMP walkthroughs surface, how governance and decision gates catch issues early, and how employees are prepared to engage with inspectors.

Explore her perspective on building readiness into everyday quality work.