Senior Compliance Manager

TetraScience

Senior Compliance Manager responsible for regulatory compliance within TetraScience. Engaging with pharma and biotech clients to validate and ensure compliance of SaaS solutions.

Posted 5/29/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

CloudGoogle Cloud PlatformVault

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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
Preferred Qualifications
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).

Benefits

Comp & perks

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

ATS Keywords

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Hard Skills & Tools

software lifecycle compliancevalidationquality assurancelast-mile validationrisk assessmentIQ/OQ/PQ scopingGxP rulesGAMP 5Computer Software AssuranceFDA frameworks

Soft Skills

executive presenceattention to detailinfluence cross-functionallyindependent senior ICcustomer-facing communicationtraining and enabling teamsguidance on validation strategybias for accountabilityethical actioncollaboration

Certifications

ASQ CQALead Auditor (ISO 9001)Lead Auditor (ISO 27001)RAC