Legend Biotech · 1 day ago
QA Investigations Lead I
Raritan, NJ
Full-time
Onsite
Entry, Mid Level
$61K/yr - $81K/yr
2+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The QA Investigations Lead I is responsible for providing quality oversight and guidance during the investigation of events in the production of personalized cell therapy products in a sterile GMP environment.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Ensure the timely completion of high-quality robust investigations with appropriate root cause(s)
Ensure appropriate Corrective and Preventative Actions (CAPA’s) are developed and implemented
Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of investigation closure and product release
Support regulatory inspections and audits by ensuring inspection readiness within facility and serving as an SME during the execution of regulatory inspections and audits as needed
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 end-to-end manufacturing issues
Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints
Perform analysis on quality indicating data and identifying trends
Contribute to maintain investigation compliance metrics
Support investigation process improvement initiatives
Job duties performed may require exposure to and handling of biological materials and hazardous chemicals
Able to work independently and also in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning
Qualification
Required
A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required
A minimum of 2-4 years relevant work experience is required
Knowledge of cGMP and GDP regulations and FDA/EU guidance related to manufacture of cell based products
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
Excellent organizational skills with the ability to simplify and clearly communicate complex concepts
Excellent verbal, written and presentation capabilities
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 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 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
Company data provided by crunchbase