QA Batch Disposition Associate Manager

Company Information

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 and natural killer (NK) cell-based immunotherapy. 

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) in 2017. 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 QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. 

Role Overview

This exempt-level position is responsible for performing a wide range of activities to support the release of drug products for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

Key Responsibilities  

• Manage the team responsible for drug product batch record review and drug product release practices.
  
• Develop positive relationships with the QA team, Quality Control, Information Technology, maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers.
  
• Independently makes appropriate and compliant GMP decisions.
  
• Lead the establishment and improvement of QA practices to ensure accurate documentation of all review and release activities for drug products, including manual and electronic practices.
  
• Establish and implement cGMP procedures to ensure compliant practices from all employees participating in the release process.
  
• Work in a team based, cross-functional environment to complete tasks required to meet business objectives.
  
• Support Investigations team by providing quality and compliance input for continuous improvement; and remediation's.
  
• Lead continuous improvement projects to reduce turnaround time for batch review / release.
  
• Require minimal direction to complete tasks, know how to attain resources and information from established internal contacts; consult with manager for decisions outside of established procedures.
• Provide direction to the batch review/ release team to meet department and business goals.
• Attend meetings and /or communicates regularly with stakeholders to report batch progress, quality batch review/ release project developments or stakeholder projects. Collaborate with (cross)functional departments to resolve issues related to batch review/release, investigations, and receipt of QC test results to allow for timely release of final product batches according to department and business plan.
  
• Review, revise, or draft Standard Operating Procedures (SOPs) in relation to the batch review/release process.
  
• Manage cross-functional projects with stakeholders to establish best practices that will reassure the target turnaround time of a CAR-T product.
  
• Maintain quality practices in accordance with state and federal regulatory requirements.
  
• Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
  
• Ensure readiness of records for regulatory inspections and internal audits.
  
• Ability to utilize multiple electronic quality systems and SAP.
  
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
  
• Strong interpersonal and written/oral communication skills.
  
• Ability to quickly process complex information and often make critical decisions with limited information.
  
• Ability to oversee multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
  
• Proficient in applying process excellence tools and methodologies.
  
• Ability to independently be responsible for a portfolio of ongoing projects.
  
• Ability to pay attention to detail