Legend Biotech
About Legend Biotech
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, the company develops advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. The organization works from three R&D sites worldwide to discover safe, efficacious, and cutting‑edge therapeutics for patients globally.
Job Summary Legend Biotech is seeking a
Quality Systems Lead
as part of the Quality team based in
Raritan, NJ .
Role Overview The Quality Systems Lead is an exempt level position responsible for supporting the quality systems processes within a cell therapy manufacturing facility. The role supports both clinical and commercial requirements in a sterile GMP environment, serves as business process owner for the Corrective and Preventive Action (CAPA) process, and ensures compliance within quality systems processes.
Key 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).
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.
Requirements
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.
Preferable 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 Legend Biotech offers a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match that vests fully on day one; equity and stock options in eligible roles; eight weeks of paid parental leave after three months of employment; and a paid time‑off policy with 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include 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, commute benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs.
Pay Range The anticipated base pay range is $107,482 USD – $141,070 USD.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. Legend’s policy is to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug‑free workplace.
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Job Summary Legend Biotech is seeking a
Quality Systems Lead
as part of the Quality team based in
Raritan, NJ .
Role Overview The Quality Systems Lead is an exempt level position responsible for supporting the quality systems processes within a cell therapy manufacturing facility. The role supports both clinical and commercial requirements in a sterile GMP environment, serves as business process owner for the Corrective and Preventive Action (CAPA) process, and ensures compliance within quality systems processes.
Key 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).
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.
Requirements
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.
Preferable 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 Legend Biotech offers a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match that vests fully on day one; equity and stock options in eligible roles; eight weeks of paid parental leave after three months of employment; and a paid time‑off policy with 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include 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, commute benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs.
Pay Range The anticipated base pay range is $107,482 USD – $141,070 USD.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. Legend’s policy is to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug‑free workplace.
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