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Document Management Supervisor

Raritan, New Jersey, United States

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.

 

Legend Biotech is seeking Document Management Supervisor as part of the Technical Operations team based in Raritan, NJ. 

Role Overview

The Document Management Supervisor will provide oversight of all GMP documents and ensure that all documents are updated and effective in alignment with the needs of Raritan site activities and document lifecycle management. They will be responsible for prescribing the correct training based on the type of changes made and managing printing of documentation and labels required for Technical Protocol runs.

Key Responsibilities  

  • Will be accountable for the hiring, development, and performance management of Technical Writing staff, they will assign personnel for document management activities as needed.
  • Oversight of the introduction of or revision process of existing SOPs in time to support Manufacturing Strategy.
  • Ensure Master Batch Record changes are made in time to support Manufacturing Strategy.
  • Ensure proper training is prescribed as per the document changes made.
  • Liaison with Operations, Technical Operations and QA to ensure alignment of changes.
  • Continuous improvement of all GMP documents to ensure they are streamlined and robust, easy to use and intuitive; to help ensure maximum prevention of operational errors and quick turnaround times.
  • Stay current regarding industry standards and ensure that all GMP documents are cutting edge and incorporate all latest regulatory and quality requirements.
  • Track relevant KPIs
  • Ensure periodic review of all GMP documents are completed on time.
  • Support documentation related activities for protocol execution at Raritan site, including controlled printing, label generation, and summary report authoring
  • Collaborate with Protocol Coordinator to ensure appropriate Tech Writer support for required protocol activities.
  • Assist with Audits, as needed

Requirements

  • Bachelor’s degree in Science, Engineering or related field or equivalent experience required.
  • 4-6 or more years of related experience in cGMP/FDA regulated industry.
  • Pharmaceutical GMP's – strong knowledge of Good Manufacturing Practices and regulatory knowledge is a requirement
  • Proficient in MS Office applications and other related IT Systems.
  • Knowledgeable in electronic Document Repositories and LMS (Learning Management Systems)
  • Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
  • Provide expertise in documentation management procedures and site documentation requirements
  • Comet knowledge is a plus

#Li-DD1

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The anticipated base pay range is:

$93,463 - $122,670 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.

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  4. Remedies for Breach. I acknowledge that in the event of any breach of this Agreement, the Company will not have an adequate remedy in money or damages, and therefore the Company shall be entitled to obtain temporary, preliminary and/or permanent injunctive relief to redress any such breach, from any court of competent jurisdiction, and that the Company’s right to obtain such relief shall not limit its right to obtain other available remedies.
  5. General. The interpretation and enforcement of this Agreement shall be governed by the laws of the State of California.  This Agreement constitutes the entire agreement between the parties concerning the subject matters hereof; it supersedes any and all prior agreements or representations, written or oral, with respect to its subject matters; and it cannot be modified except in a written agreement signed by the Company.

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