What are the responsibilities and job description for the Quality Systems Lead position at Legend Biotech US?
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing 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. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Role Overview
The Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will serve as the business process owner for the Corrective and Preventive Actions (CAPA) process and is responsible for ensuring 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).
- 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.
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. 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).
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The anticipated base pay range is:
$107,482 - $141,070 USD
Benefits:
We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 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, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
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. It is Legend’s policy 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.
Salary : $107,482 - $141,070
