President and Principal Consultant at CenPharma, I’m a quality and validation leader with 20+ years in biologics, advanced therapies, and combination products. I’ve built and led teams of up to 40, driven global QA functions across multi-site operations, and stewarded clients through inspection readiness, remediation, and commercial scale-up. My expertise spans cGMP quality systems, supplier management, CAPA, batch release, and Annex 1 environmental programs, alongside process, cleaning, aseptic, method, and computer systems validation (including MES). I’ve guided tech transfers, scale-up, and comparability strategies for NDA/BLA support, grounding decisions in ASTM E2500, ISPE guidance, and FDA Process Validation principles. MS ChE (NC State); BS ChE, magna cum laude (Virginia Tech).
