Quality Engineer

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 vendor audit programs; report findings and quality metrics to the Manager, RAQA.
• Coordinate system-related and QA training activities within Cogstate, including maintaining role-based training requirements for validated systems in the LMS, assigning training following system changes or CAPA closures, and supporting role-specific competency evidence as required.

Requirements

• Bachelor's Degree in Science, Engineering, Information Technology, or equivalent field.  Advanced degree preferred.
• Minimum 5-8 years of experience in quality assurance within a regulated clinical trials, pharmaceutical, or medical device/SaMD environment.
• Demonstrated hands-on experience with GxP system validation using GAMP 5 (2nd ed., 2022) and/or FDA Computer Software Assurance (CSA) guidance, including IQ/OQ/PQ and UAT for COTS, TPS, and eQMS platforms.
• Direct experience qualifying vendors and third-party systems: developing qualification plans, executing audits, issuing reports, and managing CAPAs to closure.
• Experience administering eQMS platforms (Qualio, Greenlight Guru, Veeva Vault QMS, MasterControl, or equivalent), including workflow configuration and quality event management.
• Familiarity with TGA, MHRA, EMA, or other international regulatory authority inspection programs.
• Experience supporting FDA QMSR or ISO 13485 third-party certification audits.
• Experience with eTMF system qualification and clinical trial data management systems.
• Experience planning and executing internal audit programs and supporting sponsor or regulatory authority audits and inspections.
• Experience with 21 CFR Part 11 and/or EU GMP Annex 11 electronic records and signature requirements.
• Demonstrated history of working independently with minimal oversight in a cross-functional environment.
• GAMP 5 (2nd ed., 2022) and FDA Computer Software Assurance (CSA): risk-based validation methodology for COTS, configured, and custom GxP software.
• 21 CFR Part 11 and EU GMP Annex 11: electronic records, audit trails, access controls, and e-signature compliance.
• QMSR (21 CFR Part 820, as amended), ISO 13485:2016, ICH E6(R3), and ISO 14971:2019.
• eQMS platform administration: quality event workflows (CAPA, NCR, deviation, change control, document management) in Qualio, Greenlight Guru, Veeva Vault QMS, MasterControl, or equivalent.
• Vendor and TPS qualification: audit planning, execution, reporting, and CAPA management.
• Internal audit methodology consistent with ISO 19011:2018.
• ALCOA+ data integrity principles applied to electronic records and GxP documentation.

Skills, Knowledge and Specialist Expertise

• Ability to train and coach cross-functional teams on GxP system compliance, ALCOA+, and audit readiness.
• Experience applying process improvement methodologies (Lean, Six Sigma, or equivalent) to QMS and validation workflows.
• Familiarity with risk-based regulatory inspection frameworks and evolving FDA QMSR enforcement priorities

What’s In It For You

• Remote Work Practices: Cogstate is a virtual first company. Cogstate employees can work from anywhere where Cogstate is registered to business within the United States, Australia, or the United Kingdom!
• Generous Paid Time-off: Cogstate employees receive 20 days of vacation leave, 10 days of personal leave and 10 paid public holidays.
• 401(k) Matching: As you invest in yourself and your future, Cogstate invests in you too: we match up to3% of your yearly salary in Cogstate’s 401k program.
• Competitive Salary: We offer competitive base salaries plus additional earning opportunities based on the position.
• Health, Dental & Vision Coverage: We've invested in comprehensive health & dental insurance options with competitive company contributions to help when you need it most. We also offer free vision insurance for all full-time employees.
• Short-Term & Long Term Disability Life Insurance: 100% employer sponsored
• Pre-Tax Benefits: Healthcare and Dependent Care Flexible Spending Accounts
• Learning & Development Opportunities: Cogstate offers a robust learning program from mentorships to assistance with programs to improve knowledge or obtain certifications in applicable areas of interest.