Senior Compliance Manager

About Tetra Science

Tetra Science is the Scientific Data and AI Company building Tetra OS, the operating system for scientific intelligence. We help the world’s leading life sciences firms turn fragmented scientific data into AI-native assets and scientific workflows that accelerate discovery, development, and manufacturing. Tetra Science’s growing ecosystem of strategic partners includes NVIDIA, Databricks, Thermo Fisher Scientific, Snowflake, Google, and Microsoft.

In connection with your candidacy, you will be asked to carefully review The Tetra Way authored by our CEO, Patrick Grady; it is impossible to overstate the importance of this document, and you should take it literally as you decide whether our mission, culture, and expectations are right for you.

A pivotal part of pharma's digital transformation is adherence to industry-accepted standards like GxP, ISO 9001, and 21 CFR Part 11. As Senior Compliance Manager, US, you will operate as an independent senior IC — accountable for ensuring Tetra Science's products and platform meet the regulatory expectations of the world’s largest pharma and biotech customers, with deep authority on FDA frameworks and the validated cloud SaaS posture US customers expect.

This is a deeply customer-facing role. You will be one of the primary regulatory voices Tetra Science puts in front of pharma and biotech Quality and Validation teams — coaching them through how the platform was qualified, how their production workflows on top of it should be validated, and how the two halves of the validated stack fit together. You will guide customers across two surfaces simultaneously: platform quality and validation (Tetra Science's own SaaS, components, and AI services, qualified under GAMP 5 / GAMP AI) and production quality and validation (the customer's last-mile, intended-use validation of the scientific workflows they build on Tetra Science).

You will help customers shorten and de-risk that last mile through documentation, templates, evidence, and direct working-session guidance.

You will partner with Product, Engineering, Security, and Quality to drive cross-functional compliance outcomes, own and continuously improve our Quality Management System, lead customer audits and supplier assessments hosted in the US, and develop the regulatory framework for AI/ML-enabled product capabilities. You will also be a key contributor to Tetra Science's GxP Package — the offering that accelerates customer validation through documentation, templates, and assurance of controlled environments.

This role reports to the VP of Product (compliance pillar) and works in close partnership with EMEA Compliance, our Security, Quality Engineering, Documentation, Product, and Engineering teams.

Serve as a senior US compliance authority for Tetra Science products, for FDA-aligned regulatory interpretation (21 CFR Part 11, Computer Software Assurance / CSA, predicate rules) and US customer expectations.

Lead customer-facing regulatory conversations as a trusted, named counterpart to pharma and biotech Quality and Validation leadership — providing direct guidance, working-session coaching, and written attestations on both platform-side qualification and customer-side production validation.

Guide customers through last-mile validation of their intended use of Tetra Science — including validation scoping, plan templates, risk assessments, traceability, and CSA-aligned testing approaches — so customer teams can validate scientific workflows on Tetra Science faster and with higher quality.

Own the platform quality and validation narrative for Tetra Science itself — how the platform, components, AI Services, and connected agents are qualified, change-controlled, and evidenced — and translate that narrative into customer-consumable artifacts (qualification summaries, GxP impact assessments, release impact letters, IQ reports).

Lead customer audits and supplier assessments hosted out of the US, including pre-audit readiness, evidence preparation, audit hosting, and findings remediation, for top-tier pharma and biotech accounts.

Own the GxP Package strategy and roadmap for…