Legend Biotech · 2 months ago
QA Validation Specialist III
Raritan, New Jersey, United States
Full-time
Onsite
Mid Level
$93K/yr - $123K/yr
4+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The QA Validation Specialist III will provide quality oversight over validation and qualification activities within a cell therapy manufacturing plant, ensuring compliance with GMP regulations and supporting clinical and commercial requirements.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facilities qualification, shipping validation, data integrity, and maintenance activities within the site
Review and approve qualification/validation documentation (specifications, protocols, reports)
Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration)
Provide expertise and solutions to issues regarding qualification and validation strategies and documentation
Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for all site systems
Assist in the development of validation and qualification related policies, procedures, templates, forms
Provides quality oversight on data integrity of systems, instruments, and equipment used at the site
Develops and evaluates quality processes and system standards to ensure compliance with applicable Legend standards, industry standards, and global regulations
Interacts with colleagues in Quality and Technical Services proactively to assess, and guide in the deployment of systems at the CAR-T Raritan Site
Review and approve change controls, SOPs, non-conformances, and CAPAs associated with qualification/validation execution and ensure effectiveness of related actions
Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements
Drive continuous improvement
Other duties may be assigned, as necessary
Qualification
Required
A minimum of 4 years relevant work experience is required
Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals
Strong knowledge of GxP compliance
Experience in cGMP regulatory body audits
Strong interpersonal and written/oral communication skills
Ability to quickly process complex information and make critical decisions with limited information
Ability to work independently and be responsible for a portfolio of ongoing projects
Ability to pay attention to details and follow procedures closely
Ability to identify and assess possible gaps and work collaboratively to address such issues
Must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision
Experience reviewing/auditing GMP documentation
Strong proficiency with using Microsoft Office applications
Preferred
Experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy
Experience in supporting cell-based products
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options are available to employees in eligible roles
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
thefly.com
2025-12-09
Company data provided by crunchbase