Senior quality assurance consulting for biotech, CDMO, and specialty pharmaceutical companies. Fractional Head of Quality retainers, scoped project engagements, and executive advisory — brought to you by a director-level operator with more than twenty years across the industry.
Every biotech and CDMO reaches a point where quality has to be built, rebuilt, or defended. If you're at one of those moments, I can help.
Currently accepting new engagements for Q3/Q4 2026
Director-level quality leadership on a scoped hourly commitment. For biotechs and CDMOs that need senior QA expertise before a full-time head of quality is right-sized to the organization. Typical engagement: 20 hours/week retainer
Scoped, deliverable-based work with defined outcomes and pricing. Common engagements include eQMS foundation builds (90 days), inspection readiness sprints (60 days), and quality system architecture reviews. Project pricing published on the Services page.
For biotech founders and small-CDMO leadership navigating quality strategy decisions ahead of scale, funding events, or regulatory milestones. Hourly advisory.
Serving the PA/NJ pharma corridor and remote nationally.
Travel available up to 40% with expenses.