Christian Spiak CAI

Christian Spiak is a Principal Consultant at CAI in the Human Performance Business Area. He has a diverse background with over 24 years industry experience in Operations, Engineering and Quality, as an individual contributor and in management. Chris is a leader with a history of building organizations and delivering results. He has extensive experience with aseptic manufacturing of sterile injectables in both Operations and Quality roles. Chris was responsible for Manufacturing Quality at an aseptic fill/finish site under modified consent decree. Working collaboratively with site leadership, he effectively closed compliance gaps which resulted in a successful PAI. He has implemented Quality Risk Management policies to effectively identify, assess and mitigate risks throughout the entire product lifecycle. Chris led an operations team who provided on the floor technical expertise to support the manufacture and release of COVID-19 vaccine. Most recently, he helped implement a streamlined approach for deviation management which utilized process mapping and data analytics to understand inefficiencies. Chris focuses on an organization’s biggest asset, their people, and helps integrate talent planning, human risk control, and human error reduction to promote operational readiness and excellence.