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Quality Assurance Investigator I

2 months ago

Raritan, New Jersey, United States Legend Biotech US Full time
Company Overview

Legend Biotech is a pioneering global biotechnology firm committed to addressing and ultimately curing life-threatening conditions. With our headquarters in Somerset, New Jersey, we are at the forefront of developing cutting-edge cell therapies utilizing a variety of technological platforms, including both autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.

In 2017, Legend Biotech entered into a significant global collaboration with Janssen, a subsidiary of Johnson & Johnson, to co-develop and commercialize ciltacabtagene autolecuel (cilta-cel). This strategic alliance aims to leverage the strengths and expertise of both organizations to enhance the potential of immunotherapy in treating multiple myeloma.

Legend Biotech is currently seeking a Quality Assurance Investigator I / II to join our Technical Operations team.

Position Summary

The Investigator will play a crucial role within the Technical Operations team, focusing on the investigation of Operations/Technical Quality Issues (QIs) to identify appropriate corrective and preventive actions in compliance with our internal regulations and the standards set by global health authorities such as the FDA. This role involves collaboration across various functions to resolve nonconformance records and implement necessary corrections.

Key Responsibilities
  • Independently lead comprehensive cross-functional investigations from start to finish.
  • Conduct thorough root cause analyses, impact assessments, and determine CAPA/EC requirements.
  • Act as a Subject Matter Expert (SME) during internal and external regulatory audits.
  • Assist in coordinating data collection and trend analysis as requested by Quality Assurance and Regulatory Affairs.
  • Identify and address potential compliance issues and opportunities for process enhancements.
  • Provide technical expertise in the Technical Operations group, with a focus on cell and gene therapy manufacturing processes.
  • Collaborate with SMEs and Quality teams to ensure the integrity of investigations and compliance with regulations.
  • Possess strong knowledge and experience with cGMP, GCP, GLP, and Quality Compliance.
  • Demonstrate excellent authorship skills and the ability to critically evaluate investigations and interpret results.
  • Effectively communicate data analysis and potential issues to management with clarity and precision.
  • Guide colleagues in understanding technical issues across interdisciplinary teams.
  • Exhibit action-oriented and customer-focused behaviors, fostering relationships and effective problem-solving.
  • Adapt quickly to new information and simplify complex data into coherent narratives to support investigations.
  • Possess intermediate to advanced skills in interpreting results and providing actionable recommendations.
  • Work collaboratively across functional groups to ensure compliance with requirements.
  • Be willing to work shifts as necessary.
Qualifications
  • A minimum of a Bachelor's degree in engineering or a related field, or equivalent experience; an advanced degree is preferred.
  • At least 5 years of experience in operations or quality assurance within a cGMP environment in the biotech or biopharma industry, with a preference for experience in Cell/Gene Therapy manufacturing.
  • Support the development of Standard Operating Procedures (SOPs) for Manufacturing and Quality Risk Assessments.
  • Ability to work autonomously, prioritize tasks, and manage multiple responsibilities effectively.
  • Advanced knowledge of cGMP regulations.
  • Strong verbal and written communication skills.
  • Experience with electronic document management systems.
  • Drive the closure of CAPA and follow up on effectiveness checks.
  • Ability to build strong partnerships and effectively collaborate with external partners in a matrixed environment.


Legend Biotech is an equal opportunity employer dedicated to fostering a diverse and inclusive workforce. We ensure equal employment opportunities without discrimination based on any protected characteristic.

Legend Biotech maintains a drug-free workplace.