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Role Description

This role is responsible for ensuring the qualification, validation, and ongoing compliance of GxP-regulated systems, including eQMS platforms, third-party systems, and vendor-supplied software. The Quality Engineer, Systems & Compliance will manage vendor quality programs, internal audits, and regulatory readiness activities to support clinical operations. Working closely with IT, DevOps, and clinical teams, this position ensures systems are validated, compliant, and maintained in a state of inspection readiness. The role requires a strong understanding of FDA, ISO, and EU regulations, along with hands-on experience in system validation, vendor qualification, and audit management. You will have the opportunity to influence system compliance strategy while contributing to the continuous improvement of quality and regulatory processes in a collaborative, remote-friendly environment.

• Lead qualification and validation of GxP-regulated systems, including eQMS, COTS, and TPS platforms, using risk-based methodologies aligned with GAMP 5 and FDA CSA guidance.
• Develop, execute, and maintain validation plans, reports, UAT scripts, and traceability matrices while ensuring compliance with 21 CFR Part 11 and EU GMP Annex 11.
• Administer and continuously improve eQMS workflows, including CAPA, deviations, NCRs, change controls, and document management.
• Manage the Vendor Qualification Program and TPS audit schedule, including initial qualification, requalification, performance monitoring, and maintenance of approved vendor lists.
• Lead internal and vendor audits end-to-end: planning, execution, reporting, and CAPA follow-up through verified closure.
• Support sponsor audits and regulatory inspections by coordinating readiness, facilitating evidence collection, and tracking closure of findings.
• Apply ALCOA+ data integrity principles to system records, validation documentation, and QMS content.

Qualifications

• Bachelor’s degree in Science, Engineering, IT, or related field (advanced degree preferred).
• Active certified auditor credential (ASQ CQA, ISO Lead Auditor, or equivalent).
• 5–8 years of experience in quality assurance within clinical trials, pharmaceutical, or medical device/SaMD environments.
• Hands-on experience with GxP system validation using GAMP 5 and FDA CSA guidance, including IQ/OQ/PQ and UAT.
• Proven expertise in vendor and third-party system qualification, audit execution, and CAPA management.
• Experience administering eQMS platforms (e.g., Qualio, Greenlight Guru, Veeva Vault QMS, MasterControl).
• Knowledge of 21 CFR Part 11, EU GMP Annex 11, ISO 13485, ICH E6(R3), and risk-based compliance methodologies.
• Strong analytical, communication, and cross-functional collaboration skills.
• Ability to work independently in a remote-first, regulated environment while maintaining inspection readiness.
• Preferred: Experience applying Lean, Six Sigma, or other process improvement methodologies to QMS and validation workflows.

Benefits

• Competitive salary range: $95,000–$105,000 USD.
• Remote-first work environment with flexible work practices.
• Generous paid time off: 20 vacation days, 10 personal days, and 10 public holidays.
• 401(k) matching up to 3% of annual salary.
• Comprehensive health, dental, and vision coverage, fully employer-sponsored short-term and long-term disability, and life insurance.
• Pre-tax benefits including healthcare and dependent care flexible spending accounts.
• Learning and development opportunities, including mentorship and support for professional certifications.

Company Description