About
Learn more about me and my goal.ABOUT JEFF GENSLER
Jeff is a respected quality thought leader in industry todayJeff has been in industry for over 30 years and has lead some of the largest remediation efforts resulting in the clearing of multiple industry critical FDA warning letters and consent decrees.
Most recently Jeff lead the successful clearing of the most contentious combination device warning letter in recent history. He lead this effort through the implementation of contemporary technology and processes. This remediation required not only full quality system remediation but remediating a critical, lifesaving auto injector to meet 99.999% reliability, which was the first in industry history. During this time he also lead the construction of a new aseptic manufacturing facility which achieved the ISPE Facility of the year 2025 designation.
Prior to his current role Jeff lead a remediation effort for the largest FDA 483 ever issued. This remediation effort was $300M and included 1,500 contractors making up 11 different workstreams. This remediation effort resulted in clearing of the warning letter in 2 years and what is today recognized as a premier quality management system in the orthopedic industry.
In his role immediately prior to that Jeff lead a full scale remediation effort that resulted in clearing of a complicated warning letter and consent degree for a facility that produced more that 2M orthopedic implants a year.
Through his years of experience in driving remediation efforts Jeff has developed an extensive playbook to drive quality management system improvements.
