More than thirty years safeguarding patients across biotechnology, sterile manufacturing, CDMOs, and Big Pharma — through FDA inspection excellence, Warning Letter remediation, and the building of quality organizations that endure.
I am a senior pharmaceutical quality executive with more than thirty years of progressive leadership across biotechnology, sterile manufacturing, CDMOs, and Big Pharma. My career has been defined by a single conviction: that quality is, at its core, a patient-safety mission.
I bring a proven record of FDA inspection excellence — including multiple zero-observation outcomes and successful Warning Letter remediation. I was recruited for Project Warp Speed to lead quality operations supporting COVID-19 vaccine production at Aldevron. My expertise spans 503B sterile compounding, biologics, vaccines, medical devices, and clinical trial management.
A Six Sigma Black Belt, I pair strategic vision with deep tactical command across every quality discipline — validation, metrology, microbiology, chemistry, environmental monitoring, regulatory affairs, supplier quality, batch release, internal auditing, and SOP management — and I lead teams that take ownership of compliance rather than fear it.
Recruited to lead quality operations supporting COVID-19 vaccine production at Aldevron during the global pandemic — quality work performed at speed, at scale, and under national scrutiny.
Delivered multiple zero-observation outcomes across my career — including Aldevron's first FDA inspection achieving zero observations and NAI status, and three successive zero-483 inspections at PCI Pharma Services.
Recruited to Teligent Pharma to remediate an FDA Warning Letter and restore compliance across global operations — meeting directly with FDA's Office of Regulatory Affairs throughout the process.
Re-executed site cleaning validation at PCI in under nine months, reducing TAMC values from 10 PPM to under 2 PPM — a process the MHRA photographed as an example of “best in class.”
Founded Alpha-Omega, growing it with triple-digit year-over-year growth to acquisition by VWR International — and was named SBA Businessperson of the Year, with recognition in the Wall Street Journal.
Directed mass and pipette calibration laboratories, engineering, and product development. Implemented lean manufacturing eliminating 25% waste, improving on-time delivery 13% and productivity 30%. Conceptualized a pipette calibration program that expanded the business over 400% in two years; secured ISO/IEC 17025 accreditation and UL/CE approvals.
Increased revenues over 75%, setting multiple company records. Promoted within one year and named Associate of the Year 1998. Managed equipment setup and validation projects including IQ/OQ/PQ protocol development and execution.
Owned QC Microbiology, environmental monitoring, Incoming QA, and regulatory compliance for a medical device manufacturer. Released lots of dental adhesives and composites; ensured compliance to US FDA QSR and ISO 13485; prepared and submitted 510(k) premarket notifications.
First site inspection achieving zero observations and NAI status.
Process photographed by the MHRA as an industry example.
Earned across four years of tenure.
Awarded to fewer than 2% of associates — earned within one year.
Recognized in the Wall Street Journal.
Following revenue records and a one-year promotion.
University of Nebraska, Kearney
Montgomery University
Mary Washington University
Villanova University · Certified ISO 9001 Internal Auditor & Trainer
The Pipette Standards Handbook — establishing a liquid-handling standard within the metrology community.
Multiple papers on liquid handling and gravimetric measurement systems.
Orphan Diseases chapter, RAPS Handbook.
Regulatory Affairs Professional Society (RAPS) · Alliance for Regenerative Medicine (ARM) · National Conference of Standards Laboratory (NCSL) · Measurement Science Conference (MSC).