Quality Engineer, Systems & Compliance

TL;DR

Quality Engineer, Systems & Compliance (GxP): Lead qualification, validation, and compliance of GxP-regulated systems including eQMS, TPS, and COTS with an accent on risk-based approach per GAMP 5 and FDA CSA guidance. Focus on vendor qualification audits, internal audits, CAPA management, and maintaining inspection readiness for FDA, EMA, and other regulations.

Location: Remote within the United States (hirify.global registered for business in US, Australia, UK)

Salary: $95,000–$105,000 USD

Company

Advancing brain health science with digital cognitive assessments trusted in over 2,000 clinical trials across 150+ countries.

What you will do

• Lead GxP system qualification and validation (IQ/OQ/PQ, UAT) for eQMS, COTS, TPS using risk-based GAMP 5 and FDA CSA.
• Develop and maintain validation documentation, RTMs, and periodic reviews compliant with 21 CFR Part 11 and EU GMP Annex 11.
• Administer eQMS workflows for CAPA, NCR, deviations, change controls, and document management.
• Manage vendor qualification program, audits, performance monitoring, and approved vendor list per ICH E6(R3) and ISO standards.
• Execute internal audits per ISO 19011, support sponsor/regulatory inspections, and track audit findings/CAPA metrics.
• Collaborate with IT, DevOps, and Clinical Ops on change controls, revalidation, and training.

Requirements

• Bachelor's in Science, Engineering, IT or equivalent; advanced degree preferred
• 5-8+ years in QA for regulated clinical trials, pharma, or med device/SaMD
• Hands-on GxP validation experience with GAMP 5/FDA CSA for COTS, TPS, eQMS (Qualio, Veeva, etc.).
• Vendor/TPS qualification, audits, CAPA closure.
• eQMS administration, 21 CFR Part 11, EU GMP Annex 11, ISO 13485.
• Internal audits, sponsor/regulatory inspection support.

Nice to have

• Familiarity with TGA, MHRA, EMA inspections.
• eTMF and clinical trial data systems.
• Process improvement (Lean, Six Sigma).
• Training/coaching on GxP compliance and ALCOA+.

Culture & Benefits

• Virtual-first remote work.
• 20 vacation days, 10 personal days, 10 holidays.
• 401(k) matching up to 3%.
• Comprehensive health, dental, vision; STD/LTD/Life insurance; FSA.
• Learning & development: mentorship, certifications.