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EXPERT ID: 1488
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Pharma & Biologics QA/Regulatory Leader | Sterile Manufacturing, Validation & Compliance Expert | Global GMP/ISO Auditor Driving Quality System Excellence

Overview

Quality and regulatory specialist with decades of experience spanning pharmaceuticals, biologics, vaccines, medical devices, diagnostics, and government-regulated manufacturing environments. Work includes leading compliance remediation programs, supporting sterile and aseptic operations, reviewing and approving validation lifecycle documentation, and managing supplier quality initiatives across global enterprises. Expertise extends across all major GMP and ISO frameworks with hands-on oversight of audits, risk analyses, investigations, and system improvements. Brings extensive exposure to high-complexity operations including consent decree environments, COVID-19 vaccine manufacturing, and global supplier networks.

Short Bio

Quality and regulatory compliance leader with deep expertise in pharmaceuticals, biologics, and medical devices. Skilled in validation, auditing, investigations, and global GMP/ISO standards supporting sterile manufacturing and regulated operations.

What I Bring

  • Expertise across pharmaceutical, biologics, CDMO, and medical device quality systems

  • Extensive experience with GMP, ISO, and global regulatory frameworks

  • Validation lifecycle management across utilities, facilities, equipment, and processes

  • Strong command of aseptic and sterile operations, including Annex 1 compliance

  • Proven success in CAPA remediation, investigations, and audit readiness

  • Supplier quality leadership across global vendor networks

  • Ability to support complex compliance programs including consent decree environments

  • Broad experience in training, coaching, and operational improvement initiatives

Key Technologies & Product Expertise

  • Parenterals, sterile injectables, oral solid dosage forms, biologics, vaccines

  • IVD technologies, tissue products, bone graft materials, molecular diagnostics

  • Cleanroom systems, isolators, RABS, environmental monitoring

  • Bioreactors (Wave, XDR), chromatography, filtration, fermentation systems

  • Utilities validation (water systems, HVAC, automation)

  • Quality systems platforms: Trackwise, SAP, MasterControl, Blue Mountain, EtQ Reliance

  • Validation frameworks: CSV, CQV, IOPQ, FAT/SAT, PPQ, URS/FRS

  • Microbiology testing, sterility testing, bioburden testing, LAL, cytotoxicity

Titles Held

  • Principal Consultant, Consulting LLC, 2011–Present

  • Senior Aseptic Coach/Trainer, Pfizer Rocky Mount, 2023

  • Supplier Quality Lead, Bristol Myers-Squibb, 2022

  • Sr. QA Validation Compliance Specialist, FujiFilm Diosynth Biotechnologies, 2020–2021

  • CAPA/Investigation Project Manager, Lupin Pharmaceuticals, 2020

  • Supplier Quality Engineer, Maquet Getinge (Datascope), 2019

  • Senior Consultant, Tissue Tech, Inc., 2019

  • Validation Quality Consultant, Illumina, 2018

  • Senior Consultant, Pfizer/Hospira Chennai, 2017

  • Supplier Controls SME, Zimmer ETEX Corporation, 2017

  • CAPA PMO Manager, Zimmer Biomet Knee Creations, 2016

  • Senior Consultant, Pfizer Catania Sicily, 2015–2016

  • Senior Consultant, Mylan/Agila/Strides, 2015

  • Senior Consultant, DePuy Synthes, 2014

  • Senior Consultant, Johnson & Johnson (multiple franchises), 2012–2013

  • Senior Consultant, Hospira, 2011–2012

  • Medical Device SME Consultant, Oriel Statamatrix, 2011

  • QA/EHS Manager, BioArray Solutions (Immucor), 2008–2011

  • QC/QA Microbiology & Chemistry Compliance Manager/Auditor, Integra Life Sciences, 2006–2008

  • Validation Compliance Supervisor (QAIV), Wyeth Vaccines, 1999–2005

  • Microbiologist, Analytical R&D, 1999–2000

  • Bacteriologist, Micro QC, Bristol-Myers Squibb, 1997–1999

  • Flow Cytometry Technologist, Medilabs, 1996

  • Data Control Lab Technician, UMDNJ, 1992–1995

Career Highlights

  • Supported COVID-19 vaccine manufacturing and validation for multiple global programs

  • Led major CAPA remediation initiatives across pharmaceutical and medical device companies

  • Conducted extensive global GMP/ISO audits and supplier quality evaluations

  • Oversaw validation of utilities, facilities, and equipment in high-risk regulated environments

  • Contributed to large-scale compliance projects tied to consent decrees and 483/warning letter responses

  • Managed supplier quality remediation for critical device and biologic components

  • Led investigations, root cause analyses, and data integrity assessments across multiple industries

  • Provided aseptic operations coaching including isolator/RABS processes and Annex 1 readiness

Education & Professional Certifications

  • B.A., Microbiology, University of Delaware

  • M.S., Environmental Biology, Montclair State University

  • M.B.A., Pharmaceutical Marketing, Fairleigh Dickinson University

  • M.S.J., Health/Drug Law, Seton Hall School of Law

Languages

English- Native

Impact

  • Strengthened global quality systems across pharmaceutical, biologics, CDMO, and medical device organizations

  • Elevated compliance readiness through leadership of validation, CAPA, deviation, and audit programs

  • Improved supplier quality control through comprehensive remediation of vendor files and quality agreements

  • Enabled accelerated readiness for sterile and aseptic operations, including COVID-19 vaccine production

  • Enhanced regulatory alignment through deployment of harmonized quality processes and training programs

Experience

29

Years of Experience

Fields of Expertise