Senior Compliance Manager
Insilico Search Partners
About the Company Our client is a fast-growing, well funded, life sciences software company building the operating system for scientific intelligence. Their platform is used by the world's leading pharma and biotech firms to accelerate drug discovery, development, and manufacturing — with strategic partners including NVIDIA, Databricks, Thermo Fisher, Snowflake, Google, and Microsoft. The Role This is a senior IC role at the intersection of regulatory compliance, customer‑facing authority, and cross‑functional product partnership. You will be one of the primary regulatory voices the company puts in front of pharma and biotech Quality and Validation teams — owning the customer relationship on all things compliance, leading audits, and partnering with Product and Engineering on architectural decisions. This is not a desk job. What You’ll Do Serve as the senior US compliance authority for 21 CFR Part 11, CSA, and predicate GxP rules Lead customer‑facing regulatory conversations with pharma and biotech QA leadership — including audit hosting, supplier assessments, and live validation guidance Guide customers through last‑mile validation of their workflows on the platform — scoping, templates, risk assessments, CSA‑aligned testing Drive the GxP Package strategy and roadmap for the US market Build the regulatory framework for AI‑enabled product capabilities (GAMP5 + GAMP AI) Own the Quality Management System (Qualio) including SOP lifecycle and audit readiness Partner with Product and Engineering on platform‑level compliance decisions Train internal customer‑facing teams on platform‑vs‑production validation framing What You Bring 12+ years in software lifecycle compliance, validation, or QA — at least 5 at a software product company (not consulting‑only) Direct experience hosting customer audits and supplier assessments for top pharma/biotech accounts Deep hands‑on knowledge of 21 CFR Part11, CSA, and GAMP5 Experience guiding pharma customers through last‑mile SaaS validation QMS ownership experience (Qualio, MasterControl, Veeva Vault QMS, or equivalent) Experience with ISO9001, ISO27001, or SOC2 TypeII for a SaaS or cloud product GAMP AI or AI/ML validation framework experience Familiarity with EU regulatory frameworks (Annex11, EU GMP) ASQ CQA, ISO Lead Auditor, or RAC certification a plus #J-18808-Ljbffr
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Barrington James
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Meet Life Sciences
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