Full-Time

Quality Systems Manager

Posted on 4/16/2024

Legend Biotech

Legend Biotech

1,001-5,000 employees

Develops cell therapies for cancer treatment

Biotechnology

Senior

Bridgewater Township, NJ, USA

Required Skills
PowerPoint/Keynote/Slides
Requirements
  • A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline or relevant experience
  • A minimum of 8 years relevant work experience
  • Experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy
  • Minimum of 2 years of leadership experience preferred
  • GxP Quality System knowledge, including relevant regulations and guidances
  • Strong written and verbal communication, analytical problem-solving, and conflict resolution skills
  • Flexible, highly motivated, with strong organization skills and ability to multitask with attention to detail
  • Ability to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment
  • Flexibility in work schedule 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 make critical decisions with limited information
  • Proficient in applying process excellence tools and methodologies
  • Ability to be responsible for a portfolio of ongoing projects independently
  • Experience developing and setting long-term objectives
  • Ability to identify and remediate gaps in processes
  • Operational experience with electronic quality systems required
  • Proficient with Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
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 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

Legend Biotech specializes in developing and manufacturing novel cell therapies for hematologic malignancies and solid tumors, leveraging cutting-edge technologies to deliver advanced treatment options for patients worldwide. The company's pipeline of cell therapies includes agents targeting diseases considered intractable and incurable, with a focus on transforming the world of oncology and medicine.

Company Stage

IPO

Total Funding

$750.5M

Headquarters

Franklin Township, New Jersey

Founded

2014

Growth & Insights
Headcount

6 month growth

19%

1 year growth

50%

2 year growth

137%
INACTIVE