Quality Engineer, Systems & Compliance

That’s why we’re seeking a Quality Engineer, Systems & Compliance iaccountable for the qualification, validation, and ongoing compliance of Vendors, GxP-regulated systems across Cogstate, including the eQMS, third-party systems (TPS), COTS applications, and vendor-supplied software. The role also owns the vendor quality program and internal audit function, supporting sponsor and regulatory audit readiness across clinical trials operations. Working in close partnership with Business Development, IT, DevOps/QC, and Clinical Trial Ops, this position ensures that systems are validated, compliant, and maintained in a state of inspection readiness in accordance with the FDA Quality Management System Regulation (QMSR, 21 CFR Part 820), 21 CFR Part 11, EU GMP Annex 11, ISO 13485:2016, ICH E6(R3), GAMP 5 (2nd ed., 2022) / FDA Computer Software Assurance (CSA) guidance, and other applicable requirements. 

Key Responsibilities

• Lead GxP system qualification and validation activities for the eQMS, COTS, and TPS using a risk-based approach aligned with GAMP 5 (2nd ed., 2022) and FDA Computer Software Assurance (CSA) guidance, covering the full validation lifecycle including IQ/OQ/PQ and UAT.
• Develop, execute, and maintain system validation plans, validation reports, UAT scripts, requirements traceability matrices (RTMs), and periodic review records; ensure documentation satisfies 21 CFR Part 11 (US) and EU GMP Annex 11 (EU) electronic records requirements.
• Administer and continuously improve eQMS quality event workflows - CAPA, nonconformance records (NCR), deviations, change controls, and document management — across eQMS platform.
• Lead and maintain the Vendor Qualification Program and Third-Party System (TPS) audit schedule, including initial qualification, periodic requalification, performance monitoring, and maintenance of the approved vendor/TPS list in alignment with ICH E6(R3), ISO 13485/ISO 9001/ISO 27001 supplier control requirements, and other applicable requirements.
• Lead vendor qualification and audit activities end-to-end: scope definition, audit plan development, execution (on-site or remote), report issuance, and CAPA follow-up through to verified closure.
• Apply ALCOA+ data integrity principles across all system records, validation documentation, and QMS content; ensure eQMS configurations enforce audit trail, access controls, and data integrity requirements per 21 CFR Part 11 and Annex 11.
• Manage system change controls, post-change impact assessments, and revalidation activities; maintain validated state inventory and support system periodic review cycles.
• Identify and escalate GxP system compliance risks; lead root cause analysis and drive CAPA for system-related quality events, deviations, and audit findings.
• Collaborate with IT and DevOps/QC on software release validation, infrastructure qualification, and integration testing in regulated environments.
• Plan, execute, report, and manage follow-up on the internal audit program per established schedule, applying a risk-based methodology consistent with ISO 19011:2018; maintain inspection readiness per FDA Compliance Program 7382.850.
• Own and maintain the vendor and TPS audit schedule; lead vendor audits, remote desktop reviews, and surveillance assessments; issue audit reports and manage findings through to closure.
• Support sponsor audits and regulatory authority inspections: coordinate readiness activities across functions, facilitate audit hosting, assist with evidence preparation and retrieval, draft audit responses and CAPA plans, and track finding closure through effectiveness verification.
• Track and trend audit findings, CAPA metrics, and systemic quality issues across the internal and vend...