Quality Systems Leader – Cell Therapy

Legend Biotech USA

Raritan (NJ)

On-site

USD 150,000 - 210,000

Full time

10 days ago

Application generator

A complete application in a minute — tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

Legend Biotech is seeking an Associate Director, Quality Systems, based in Raritan, NJ, to lead quality systems oversight at a CAR-T manufacturing site within a sterile GMP environment. This role chairs the Site Quality Leadership Team and directs document control, investigations, CAPA, change control, site quality metrics, and QA oversight of laboratories, ensuring compliance and inspection readiness.

You will manage a team of quality systems specialists, drive QRM, and collaborate with

Qualifications

Bachelor's degree in Science, Engineering, Biotechnology, Pharmacy, Information Science, Biology is required; advanced degree preferred.
Minimum 10 years of quality experience in a cGMP-regulated facility, with leadership of quality systems, investigations, CAPA, governance, and regulatory-inspection readiness.

Responsibilities

Provide quality systems oversight for the CAR-T manufacturing site and lead the Quality Systems, Systems Support, and Investigations teams.
Lead cross-functional projects, coordinate with Manufacturing, QC, Engineering, Supply Chain, and Operations to harmonize procedures and drive risk-based decision making.
Drive Quality Risk Management (QRM) implementation and cross-functional risk assessments to identify and mitigate quality, compliance, and operational risks.
Monitor investigations, CAPAs, changes, and process improvements; ensure timely closure and effective root-cause analysis.
Present quality metrics, trends, and risks to site leadership and governance forums; mentor investigators and cross-functional teams on risk identification and mitigation strategies.