Bringing pharmaceutical-grade rigor to biotech and pharma organizations through both independent consulting and contract engagements. Method validation, GMP systems, and FDA audit support — on your timeline and budget.
Available for independent consulting engagements and contract roles — project-based, retainer, or long-term on-site and remote positions across biotech and pharma.
I'm Kyle Hunt, a QC and compliance consultant and contractor based in Winston-Salem, NC. I spent 8+ years building and running quality control programs at pharmaceutical and biotech companies — spanning early clinical-stage development through commercial manufacturing.
I've led method validations across four manufacturing sites simultaneously, served as an SME during FDA regulatory audits, and built QC systems that reduced review turnaround time by 40% and eliminated manual calculation errors by 91%.
Now I bring that same level of rigor to organizations through independent consulting and contract engagements. Whether you need a project-based consultant, an embedded contractor, or ongoing QC advisory support — I can step in quickly and deliver results.
Most engagements go from first call to active work within two weeks. No lengthy procurement cycles.
The fastest way to get started is a 30-minute discovery call. Tell me what you're working on and I'll give you a straight answer about whether and how I can help — at no charge.