QA Control Specialist II

QA Change Control Specialist II – Bio Space, Raritan, NJ

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.

The QA Change Control Specialist II role is an exempt level position that provides quality oversight over the change control process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will manage change control activities throughout the life cycle.

• Support and streamline the site change control process.
• Participate in change control processes 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‑functional projects with multiple 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.
• Drive continuous improvement.
• Have advanced computer skills to increase department productivity and broaden technical knowledge.
• Work in a collaborative team setting with quality counterparts that include Manufacturing Operations, Quality Control, and Operations Technical Support.

• A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline.
• Minimum of 2 years relevant work experience, preferably in a cGMP manufacturing facility, quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• Knowledge of GxP Quality Systems, including relevant regulations and guidances (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, analytical problem‑solving and conflict resolution skills.
• IT system lifecycle knowledge – requirements gathering, change management, implementation and continuous support – is a plus.
• Flexible, highly motivated, with strong organization skills and ability to multitask with attention to detail.
• Must manage shifting priorities to meet critical deadlines in a fast‑paced and dynamic environment.
• Effective interpersonal skills for communication across all levels of the organization.
• Ability to work independently with a high degree of accountability.
• Proficient knowledge of Microsoft Office (Outlook, Excel, Word, PowerPoint).
• Experience in quality metrics reporting, analysis and process improvement techniques is a plus.

The anticipated base pay range is $75,972 – $99,713 USD.

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. Highlights include medical, dental, and vision insurance, a 401(k) retirement plan with company match vested fully on…