Senior Compliance Manager, US

About TetraScience

TetraScience 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. TetraScience’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.

About the Role

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 TetraScience'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 TetraScience 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 (TetraScience'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 TetraScience). 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 TetraScience'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

What You Will Do

Serve as a senior US compliance authority for TetraScience 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 TetraScience — including validation scoping, plan templates, risk assessments, traceability, and CSA-aligned testing approaches — so customer teams can validate scientific workflows on TetraScience faster and with higher quality.

Own the platform quality and validation narrative for TetraScience 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 the US market — including documentation, validation templates, controlled environment attestations, and last-mile validation enablement — to reduce burden on pharma compliance and QA teams.

Improve the regulatory framework for AI-enabled product capabilities: GAMP 5 + GAMP AI categorization, model validation expectations (e.g., Life Cycle Software Assurance, vision and language models), and customer-facing AI impact assessment artifacts.

Own and continuously improve the Quality Management System in Qualio, including SOP lifecycle, ensuring it remains audit-ready and aligned with evolving US regulatory expectations.

Partner with Product and Engineering on platform-level compliance decisions — audit trail design, electronic signatures (21 CFR 11.50), data residency, multi-tenant vs. single-tenant validated environments — acting as the regulatory voice in architectural trade-offs.

Maintain compliance readiness for ISO 9001 and other certifications, including annual surveillance audits, recertifications, and continuous evidence collection.

Independently lead cross-functional remediation when audit findings, customer escalations, or regulatory gaps surface — without requiring day-to-day direction.

Train and enable customer-facing teams (Sales, Solutions Architecture, Implementation, Customer Success) on platform-vs-production validation framing, GxP Package usage, and the boundaries of TetraScience's qualification versus customer last-mile validation.

Contribute to Sales, Implementation, and Customer Success engagements as the US regulatory subject matter expert, including RFP/RFI responses, compliance matrices, and executive-level customer compliance discussions.