Legend Biotech · 3 months ago
QA Investigations Lead III
Raritan, New Jersey, United States
Full-time
Onsite
Mid Level
$81K/yr - $107K/yr
4+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The QA Investigations Lead III is responsible for providing quality oversight over the production of personalized cell therapy and ensuring compliance with regulatory standards in a sterile GMP environment.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs
Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues
Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints
Review and approve manufacturing procedures
Support regulatory inspections and audits by ensuring inspection readiness within facility
Perform internal housekeeping audits
Perform analysis on quality indicating data and identifying trends
Provide oversight for trending of quality compliance metrics
Qualification
Required
A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required
A minimum of 4 years relevant work experience is required
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices
Great attention to detail and ability to follow the procedures
The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision
Good written and verbal communication skills are required
Ability to summarize and present results, and experience with team-based collaborations is a must
Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk
Must exhibit strong leadership skills and effectively develop others
Ability to collaborate well with stakeholders, customers and peers
Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality
Must be able to discern the criticality of issues and to communicate to management regarding complex issues
Ability to manage conflict and issues that arise with internal or external customers
Preferred
Experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy
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
legacy.thefly.com
2026-01-22
2026-01-22
Company data provided by crunchbase