QA Investigations Lead II

Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. 

Role Overview

 The QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and complaint product supply.

Key Responsibilities  

• Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs.
• Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
• Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
• Review and approve manufacturing procedures.
• Support regulatory inspections and audits by ensuring inspection readiness within facility.
  
• Perform internal housekeeping audits.
  
• Perform analysis on quality indicating data and identifying trends.
  
• Provide oversight for trending of quality compliance metrics.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning.

Requirements

• A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
  
• Great attention to detail and ability to follow the procedures.
  
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
  
• Good written and verbal communication skills are required.
  
• Ability to summarize and present results, and experience with team-based collaborations is a must.
  
• Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
  
• Must exhibit strong leadership skills and effectively develop others.
  
• Ability to collaborate well with stakeholders, customers and peers.
  
• Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
  
• Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
• Ability to manage conflict and issues that arise with internal or external customers.

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