We are not hiring consultants. We are hiring practitioners — people who have authored protocols at 2 AM before a batch, managed investigators through an FDA 483, and felt the weight of a CPV OOS in a biologics facility. If that's you, and you believe AI can make regulated manufacturing fundamentally better, we need to talk.
"We are building the practice that bridges two worlds that have never met on equal terms — the discipline of GxP compliance and the power of agentic AI. The people who build this with us will be the ones who defined what it means to do both, simultaneously, without compromise. This is not a job. It is a founding statement."
We are a flat team of specialists. You will own your domain. You will work directly with clients. You will never be asked to write a slide deck before you understand the problem.
Every team member owns a domain end-to-end. If you're our CPV lead, you design the strategy, write the validation plan, deploy the AI, and defend it at inspection. No handoffs. Full accountability.
We don't use junior staff to pad capacity. Every client interaction is led by someone who has done the work — inside regulated facilities, not just read the guidance documents.
You will work alongside our agentic AI platform every day — as a collaborator, a validator, and an instructor. Your GxP judgment is what makes the AI defensible. The AI makes your judgment faster.
Our clients operate in the US, EU, and APAC. Our team works remotely with structured cadences — because the best CQV and GxP talent is not in one city, and neither are the facilities we serve.
We are early. The people who join now will define the service lines, the AI tools, the culture, and eventually the firm's direction. Early equity participation reflects that reality.
We write things that hold up under FDA scrutiny. That standard applies to every internal document, every client deliverable, and every argument we make internally. Rigor is not negotiable here.
We compete for the best CQV and GxP talent in the market. That means market-rate compensation, meaningful equity, and a structure that rewards your contribution directly.
Market-rate base salary benchmarked to senior industry roles. No artificial compression.
Meaningful equity participation for all founding team members. You build it — you share it.
Work from anywhere. Client travel when meaningful. Zero commute for everything else.
Annual education budget for courses, conferences, certifications, and industry memberships.
All roles are remote-first. Global candidates welcome where regulatory context applies.
No open roles in this department right now. Send a general application anyway.
Send general applicationIf you have deep expertise in pharmaceutical validation, GxP compliance, biologic manufacturing, CSA, data integrity, or AI in regulated environments — we want to hear from you. Tell us what you do and what you've built. We'll figure out how you fit.