I've spent more than two decades building, running, and rebuilding quality systems inside pharmaceutical companies — and one recent chapter running an operating venture through to a successful exit. That combination is what BB Quality Solutions offers to biotech and CDMO leaders: senior director-caliber quality expertise, delivered by someone who understands the operational and financial reality of small-to-mid-size pharmaceutical companies from the inside.
I've configured MasterControl eQMS from a hybrid EDMS to a fully paperless system in nine months — including URS authorship, module architecture (deviations, CAPAs, change controls, batch records, risk, audit), and risk-based computer system validation. I've served as Acting Director of Quality Assurance at a bioconjugation CDMO, successfully hosting an unannounced European regulatory inspection during a director-level transition with no critical findings requiring escalation. I've cleared a 22-record batch disposition backlog in nine months by redesigning the cross-functional workflow that created it, and built the visual management system that sustained the improvement after I transitioned. I've owned quality agreements with clients and vendors, and I've been recruited across companies by former colleagues who wanted me on their side of the build.
Between 2022 and 2025, I built and exited an agritech venture that ran with GMP-caliber discipline — including a full business plan, financial modeling, quality system design, and SharePoint-based document control from scratch. In late 2024, my partner and I led the acquisition process for a multi-generational greenhouse business as a scale expansion play; the deal ultimately terminated when federal financing was withdrawn during the administration transition, with our deposit returned following diligence findings we surfaced. That period taught me something you can't learn from inside a corporate quality function: what it feels like to be the person paying the bills when a quality decision has to be made. That perspective is what I bring to founder and CEO conversations now.
Bachelor of Arts in Biochemistry from Immaculata University. Currently completing ASQ Certified Manager of Quality/Organizational Excellence (September 2026) and ASQ Six Sigma Green Belt (August 2026). MasterControl Super User training completed May 2023. Radiation Safety Certified through NIH. Earlier SAP Quality Management certifications supporting my Super User role across MedImmune's sites.
I'm direct, I'm honest, and I don't inflate scope or oversell what a project requires. I've been the quality professional in the room when leadership wanted an easier answer than the compliant one, and I've been the operator in the room when the compliant answer cost money we needed. Both of those experiences shape how I show up for clients now.
If we work together, you'll get a senior perspective that reflects both sides — and a written scope that we both agree to before any work begins.
If that sounds like the kind of partner you're looking for, let's talk.