Quality Compliance Lead

2 weeks ago

Raritan, United States Legend Biotech Full time

Legend Biotech is seeking Quality Compliance Lead

as part of the Quality

team based in Raritan, NJ.

Role Overview

The Quality Compliance- Lead Auditor CAR-T is responsible for regulatory compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

Key Responsibilities

Successfully support the implementation, execution, and improvement of the internal audit process.

Support the planning and execution of internal audits for all quality system areas for the manufacturing site; write audit reports, issue audit observations and follow-through to ensure satisfactory resolution and closure of each internal audit.

Coordinate front room/ back room activities for health authority audits and independent audits; manage audit responses and observation resolution.

Drive site compliance to regulatory, enterprise, and global requirements through building positive relationships across functions, to meet unified business objectives.

As required, run reports and conduct data analysis to support monitoring of key performance indicators; support the preparation of compliance data for the monthly CRB & quarterly QSMR presentations.

Fulfills the Quality System audit module site key user responsibilities - represent the Raritan site in global forums/ team meetings, mentor site users for audit process, and control access to any systems used to support audits/inspections.

Provide support to quality systems team, ad hoc, for activities such as annual product review, site risk register, or internal quality agreements.

Develops and delivers training for specific quality system topics, in both classroom setting and individual interactions

Support the creation, assessment and closure as needed of corrective actions, change controls, or audit actions related to the site

Ensures and maintains a state of inspection readiness.

Perform compliance walkthroughs as part of audit/inspection readiness activities to ensure that the site is an inspection ready state.

Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Requirements

A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required

A minimum of six (6) years of experience in Quality Assurance/ Quality Systems or Compliance with a minimum of 4 of those within laboratories or laboratory oversight

Experience conducting internal audits (self-inspection), including writing audit reports, writing observations, and follow-through of observation resolution

Experience in front room/ back room roles for external audits

Experience working with quality systems is required

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