Quality Engineer – Systems, Compliance

Role Overview

• Lead GxP system qualification and validation activities for the eQMS, COTS, and TPS.
• Develop, execute, and maintain system validation plans, validation reports, UAT scripts, and periodic review records.
• Administer and continuously improve eQMS quality event workflows
• CAPA, nonconformance records (NCR), deviations, change controls, and document management.
• Lead and maintain the Vendor Qualification Program and Third-Party System (TPS) audit schedule.
• Lead vendor qualification and audit activities end-to-end.
• Apply ALCOA+ data integrity principles across all system records.
• Manage system change controls, post-change impact assessments, and revalidation activities.
• Identify and escalate GxP system compliance risks; lead root cause analysis and drive CAPA for system-related quality events.
• 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.
• Own and maintain the vendor and TPS audit schedule; lead vendor audits, remote desktop reviews, and surveillance assessments.

Requirements

• Bachelor's Degree in Science, Engineering, Information Technology, or equivalent field.
• Active certified auditor credential (ASQ CQA, ISO Lead Auditor, or equivalent) required at hire.
• 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.
• Direct experience qualifying vendors and third-party systems.
• Experience administering eQMS platforms (Qualio, Greenlight Guru, Veeva Vault QMS, MasterControl, or equivalent).
• 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.

Tech Stack

• Vault

Benefits

• Remote Work Practices: Cogstate is a virtual first company.
• Generous Paid Time-off: 20 days of vacation leave, 10 days of personal leave and 10 paid public holidays.
• 401(k) Matching: Cogstate matches up to3% of your yearly salary in the 401k program.
• Competitive Salary: We offer competitive base salaries.
• Health, Dental & Vision Coverage: Comprehensive health & dental insurance options with competitive company contributions.
• Short-Term & Long Term Disability Life Insurance: 100% employer sponsored.
• Pre-Tax Benefits: Healthcare and Dependent Care Flexible Spending Accounts.
• Learning & Development Opportunities: Robust learning program from mentorships to assistance with programs to improve knowledge or obtain certifications.