Tech Stack

Description

You will lead the qualification, validation, and compliance of GxP-regulated systems, manage the vendor quality program, and support internal and sponsor audits. Your work ensures inspection readiness across clinical trial operations at a company advancing brain health assessments.

Requirements

• Bachelor's Degree in Science, Engineering, IT or equivalent field; advanced degree preferred.
• 5-8+ years of quality assurance experience in a regulated clinical trial environment.
• Knowledge of FDA QMSR, 21 CFR Part 11, EU GMP Annex 11, ISO 13485, ICH E6(R3), GAMP 5.
• Experience with eQMS platforms (e.g., Qualio, MasterControl, Greenlight Guru).
• Experience in computer system validation (CSV) and data integrity (ALCOA+) principles.

Responsibilities

• Lead GxP system qualification and validation activities for eQMS, COTS, and TPS using risk-based approach (GAMP 5, FDA CSA).
• Develop and maintain system validation plans, reports, UAT scripts, RTMs, and periodic review records.
• Administer and improve eQMS quality event workflows (CAPA, NCR, deviations, change controls).
• Lead vendor qualification program and TPS audit schedule; perform on-site/remote audits and manage findings to closure.
• Support sponsor audits and regulatory inspections; coordinate readiness, facilitate hosting, and draft audit responses.