Legend Biotech · 2 months ago
Quality Systems Lead
Raritan, NJ
Full-time
Onsite
Mid Level
$107K/yr - $141K/yr
4+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The Quality Systems Lead will support quality systems processes within a cell therapy manufacturing facility, ensuring compliance with GMP and overseeing the CAPA program.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
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 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
Qualification
Required
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
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
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)
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes 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
Peer-to-peer recognition programs
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
2025-12-18
Company data provided by crunchbase