Quality Director, Quality Consulting Services
Nick boasts a wealth of experience as a seasoned QA professional, boasting a remarkable tenure of over three decades in FDA-regulated industries. His extensive background encompasses various sectors, including medium and large-scale manufacturing environments spanning all categories of medical devices, the meticulous aseptic processing of small parenteral products, a broad spectrum of oral dosage forms within the pharmaceutical realm, and most recently, a foray into the world of dietary supplements.
For nearly two decades, Nick has served as the primary management representative, affording him unparalleled expertise in liaising with regulatory agencies. His adeptness at deciphering regulatory intent and crafting solutions that benefit all stakeholders is a testament to his proficiency. Moreover, Nick has delved deeply into the intricacies of conducting QC out-of-specification investigations, addressing Form 483 citations, and orchestrating the remediation of warning letters.
In the realm of education, Nick has been a dedicated proponent of GMP (Good Manufacturing Practices) and SPC (Statistical Process Control) training for numerous years. His approach prioritizes interactivity, employing innovative methods such as games and demonstrations to captivate and engage his trainees effectively.
Beyond his professional endeavors, Nick finds solace and fulfillment in his personal life. He shares his home with a loving wife and two lively Bengal kittens. In his leisure time, he embraces a diverse range of hobbies, crafting his own wines, creating intricate 3D printed gadgets and puzzles, and skillfully turning pens and other items on a lathe. Nick’s adventurous spirit shines through as he indulges in his passion for travel, exploring the world’s wonders both above and below the surface through scuba diving, sailing, and skiing.
Area of Expertise: BSc. Physics, Rensselaer Polytechnic Institute