Senior Compliance Manager, US

TetraScience • Cambridge, MA

7h • Remote

About The Position

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

Requirements

• 12+ years of progressive experience in software lifecycle compliance, validation, or quality assurance, with at least 5 years in a software product company (not consulting-only).
• Direct, repeated customer-facing experience presenting and defending regulatory positions to pharma or biotech compliance, QA, and CSV teams — including audit hosting, supplier assessments, and live working-session guidance on validation strategy.
• Demonstrated experience guiding customers through last-mile / intended-use validation of a commercial SaaS or cloud product — including IQ/OQ/PQ scoping, validation plan authoring, risk assessment, and CSA-aligned testing.
• Demonstrated ability to operate as an independent senior IC — setting strategy, driving cross-functional execution, and influencing leadership without explicit hierarchical authority.
• Deep working knowledge of FDA frameworks relevant to validated software: 21 CFR Part 11 (electronic records and signatures, including 11.10(e) and 11.50), Computer Software Assurance (CSA), 21 CFR Part 820 where applicable, and predicate GxP rules (GMP, GLP, GCP).
• Hands-on experience preparing for and supporting ISO 9001, ISO 27001, SOC 2 Type II, or HIPAA audits — ideally for a SaaS or cloud product serving regulated industries.
• Experience with GAMP 5 (and ideally GAMP AI) — applying categorization and validation rigor to commercial SaaS and AI/ML-enabled product features, and explaining that rigor to customer compliance teams.
• Track record of leading customer audits and supplier assessments for top-20 pharma and biotech companies
• Experience owning a Quality Management System (Qualio, MasterControl, Veeva Vault QMS, or equivalent), including SOP authoring, policy lifecycle, training records, and CAPA.
• BS in computer science, life sciences, engineering, or related discipline.
• Strong written and verbal communication, executive presence in customer-facing settings, attention to detail, and a documented bias for accountability and ethical action.
• Proven ability to influence cross-functionally and change behavior in a high-growth software organization where compliance must scale alongside product velocity.
• Ability to work US Eastern hours

Nice To Haves

• Certifications such as ASQ CQA, Lead Auditor (ISO 9001 / ISO 27001), or RAC.
• Direct experience validating cloud-based or SaaS GxP systems used by pharma R&D, manufacturing, or QC labs — on both the vendor side and the customer-implementation side.
• Familiarity with EU regulatory frameworks (Annex 11, EU GMP, GDPR, EU Reg 536/2014) sufficient to partner effectively with EMEA Compliance.
• Experience building AI/ML validation frameworks in a commercial SaaS context, with reference customers willing to attest.
• Hands-on experience with compliance automation tooling and "compliance-as-code" concepts (evidence collection, control mapping, GRC platforms).

Responsibilities

• 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.

Benefits

• Competitive compensation
• Stock options in a VC-backed Series C company
• 100% employer-paid benefits for all eligible employees and immediate family members
• 401(k)
• Unlimited paid time off (PTO)
• Flexible working arrangements
• Company-paid Life Insurance, LTD/STD

What This Job Offers

• Job Type: Full-time
• Career Level: Senior