Quality Systems Lead

About Legend Biotech

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, the company develops advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. The organization works from three R&D sites worldwide to discover safe, efficacious, and cutting‑edge therapeutics for patients globally.

Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ
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The Quality Systems Lead is an exempt level position responsible for supporting the quality systems processes within a cell therapy manufacturing facility. The role supports both clinical and commercial requirements in a sterile GMP environment, serves as business process owner for the Corrective and Preventive Action (CAPA) process, and ensures compliance within quality systems processes.

• Provide oversight to the CAPA program for the CAR‑T manufacturing site.
• Oversee metrics, trending, and reporting of relevant quality systems records.
• Support CAPA site governance program.
• Drive continuous improvement of quality systems processes.
• Ensure compliance with current Good Manufacturing Practices (cGMP).
• multiple and complex cross‑functional projects with many stakeholders.
• Support other quality systems activities, as needed.
• Support drafting, review and approval of standard operating procedures and any other required documentation.
• Collaborate with functional departments to resolve issues.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Require minimal direction to complete tasks, know how to get resources and information from established internal contacts, and consult with supervisor for decisions outside established processes.

• A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline or relevant experience is required.
• A minimum of 4 years relevant work experience is required.
• Preferable experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR parts 210, 211, 1271, 600, 601, 610, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).
• Strong written and verbal communication, analytical problem solving and conflict resolution skills.
• Flexible, highly motivated, with strong organization skills, ability to multitask with attention to detail.
• Must be able to manage shifting priorities to meet critical deadlines in a fast‑paced and dynamic, growing environment.
• Flexibility in work schedule is required.
• Effective interpersonal skills with the ability to communicate across all levels of the organization.
• Ability to work independently with a high degree of accountability.
• Ability to quickly process complex information.
• Proficient in applying process excellence tools and methodologies.
• Ability to independently be responsible for a portfolio of ongoing projects.
• Ability to work with and lead others in a team environment.
• Experience developing and setting long‑term objectives.
• Ability to identify/remediate gaps in processes.
• Operational experience with electronic quality systems is required.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).

Legend Biotech offers a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match that vests fully on day one; equity and stock options in eligible roles; eight weeks of paid parental leave after three months of employment; and a paid time‑off policy with 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays.

Additional benefits include flexible spending and health savings accounts, life and AD&D…