Associate Director, Quality IT

Ensure that staff are developed and knowledgeable of regulatory expectations.

Assist with inspection readiness efforts and program implementation.

Support GxP regulatory inspections as required.

Support Legend’s regulatory program and monitor the regulatory landscape to stay informed of regulatory trends and developments.

Support development and gathering of quality metrics for Legend’s Quality Management Review (QMR).

Strong knowledge of global GxP regulations (US is a must; EU, China and GTP are considered a plus).

$163,468

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$214,551 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

The Associate Director, Quality IT is responsible for leading the IT Quality team and providing IT Quality oversight for the implementation and lifecycle management of GxP IT systems within Legend Biotech.

This position will ensure that GxP electronic systems(eSystems) adhere to both national and international regulatory guidelines on Electronic Records, Electronic Signatures, Data Integrity, cGMP, GCP, GLP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines.

Ensure that GxP IT systems, processes and records adhere to Legend CSV and SDLC procedures, FDA, EMEA and other regulatory requirements.

Provide IT Quality oversight for GxP eSystem enhancement and validation activities inclusive of documentation and change controls.

Direct and manage the IT Quality Team activities in accordance with compliance and business priorities.

Contribute to the development and enforcement of applicable standard operating procedures at Legend.