QA Control Specialist III

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop 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 వైర, we apply these innovative technologies to discover safe, efficacious, and cutting‑edge therapeutics for منتصف patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, a pharmaceutical company of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership combines strengths and expertise to advance this immunotherapy in the treatment of multiple myeloma.

QA Change Control Specialist II – Quality team, Raritan, NJ

The QA Specialist, Change Control role is an exempt level position with responsibilities for quality oversight of the change control process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role manages change control activities throughout the lifecycle.

• Support and streamline the site change control process.
• Participate in change control from initiation through completion.
• Schedule and participate in site change control review board meetings.
• Manage change control metrics reporting.
• Collaborate with functional departments to resolve issues.
• Support drafting of standard operating procedures.
• Support cross
  
  Distinct projects with many stakeholders.
• Participate in the training program for new members.
• Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Review change controls, SOPs, and other documentation.
• Require minimal direction to complete tasks and consult with supervisor for decisions outside established processes.
• Driver continuous improvement.
• Have advanced computer skills to increase department productivity and broaden technical and scientific knowledge.
• Work in a collaborative team setting with quality counterparts that include Manufacturing Operations, Quality Control, and Operations Technical Support.

• Minimum of a Bachelor’s Degree in Science, Information Science, or equivalent technical discipline.
• Minimum of 2 years of relevant work experience, preferably in a cGMP manufacturing facility, in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• GxP Quality лёSystem knowledge and relevant regulations (e.g., 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).
• Operational experience with electronic quality systems.
• Familiarity with core Quality Management System processes.
• Strong written and verbal communication skills, and analytical problem‑solving and conflict‑resolution skills.
• IT system lifecycle knowledge, including requirements gathering, change management, implementation, and continuous support.
• Flexible, highly motivated, with strong organization,Deletion, and attention to detail.
• Ability to manage shifting priorities to meet critical deadlines in a fast‑paced and dynamic environment.
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Furthermore, effective interpersonal skills with ability to communicate across all levels of the organization.
• Ability to work independently with a high degree of accountability.
• Proficient knowledge of Microsoft Office.
• Experience in quality metrics reporting, analysis, and process improvement techniques.
• Proficiency with Microsoft Office applications (Outlook, Excel, Word, PowerPoint).

The anticipated base pay range is: $81,273 USD – $106,669 USD.

We offer a best‑in‑class benefits package, including medical, dental, and vision insurance; a 401(k) retirement plan with company match that vests fully on day one; equity and stock options for eligible employees; eight weeks of paid parental leave after three months of employment; and a paid time‑off policy that includes vacation days, personal days, sick time, 11 حوال belangen holidays, and 3 floating holidays.

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