Quality Engineer, Systems & Compliance

Key Responsibilities:

• Lead GxP system qualification and validation activities for the eQMS, COTS, and TPS.
• Develop, execute, and maintain system validation plans, validation reports and UAT scripts.
• Administer and continuously improve eQMS quality event workflows.

Vendor Qualification Program:

• Lead and maintain the Vendor Qualification Program and Third-Party System (TPS) audit schedule.
• Lead vendor qualification and audit activities end-to-end: scope definition, audit plan development and execution.
• Apply ALCOA+ data integrity principles across all system records, validation documentation, and QMS content.

Audit Program:

• Plan, execute, report, and manage follow-up on the internal audit program per established schedule.
• Support sponsor audits and regulatory authority inspections.
• Track and trend audit findings, CAPA metrics, and systemic quality issues across the internal and vendor audit programs.