Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, New Jersey. 

Role Overview

The Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will serve as the business process owner for the Corrective and Preventive Actions (CAPA) process, and is responsible for ensuring compliance within quality systems processes.

Key Responsibilities

• Lead the CAPA program for the CAR-T manufacturing site.
• Oversee metrics, trending, and reporting of relevant quality systems records.
• Implement and lead CAPA site governance program.
• Drive continuous improvement of quality systems processes.
• Implement processes to 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 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

Requirements

• A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline or relevant experience is required.
• A minimum of 8 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A minimum of 2 years of leadership experience is preferred.
• 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 and often make critical decisions with limited 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).

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