Quality Systems Lead

Quality Systems Lead – Legend Biotech

Location: Raritan, New Jersey

Seniority level: Mid‑Senior level

Employment type: Full‑time

Job function: Quality Assurance

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing 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. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious, and cutting‑edge therapeutics for patients worldwide.

Role Overview: The Quality Systems Lead is an exempt level position that supports quality systems processes within a cell therapy manufacturing facility to meet both clinical and commercial requirements in a sterile GMP environment. The role serves as the business process owner for the Corrective and Preventive Actions (CAPA) process and ensures compliance within quality systems processes.

Key Responsibilities:

• 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).
• Manage 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 other required documentation.
• Collaborate with functional departments to resolve issues.
• Perform tasks in a manner consistent with safety policies, quality systems and cGMP requirements.
• Require minimal direction to complete tasks, obtaining resources and information from established internal contacts, and consulting with supervisor for decisions outside established processes.

Requirements:

• A minimum of a Bachelor’s Degree in Science, Engineering, or equivalent technical discipline or relevant experience is required.
• At least 4 years of relevant work experience; experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy is preferred.
• Knowledge of GxP quality systems, 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.
• Highly motivated, organized, and able to multitask with attention to detail.
• Ability to manage shifting priorities to meet critical deadlines in a fast‑paced, dynamic, growing environment.
• Flexibility in work schedule.
• Effective interpersonal skills with ability to communicate across all levels of the organization.
• Ability to work independently with a high degree of accountability.
• Ability to process complex information quickly.
• Proficiency in applying process‑excellence tools and methodologies.
• Experience leading ongoing projects and setting long‑term objectives.
• Ability to identify and remediate gaps in processes.
• Operational experience with electronic quality systems.
• Proficiency with Microsoft Office (Outlook, Excel, Word, PowerPoint).

Anticipated Base Pay Range: $107,482 – $141,070 USD.

Benefits: We offer a best‑in‑class benefits package that includes medical, dental, and vision insurance; a 401(k) retirement plan with company match; equity and stock options for eligible roles; eight weeks of paid parental leave after three months of employment; paid time off including 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays; flexible spending and health savings accounts;

life and AD&D insurance; short‑ and long‑term disability coverage; legal assistance; supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance; commuter benefits; family planning and care resources; well‑being initiatives; and peer‑to‑peer…