QA Investigations Lead II/III

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

Role Overview

The QA Investigation Lead is an exempt level position reporting to the QA Investigation Supervisor within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events that occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate for this role demonstrates the quality mindset to strive for excellence, continuous improvement and ethical conduct in attaining and maintaining the highest levels of quality.

Key Responsibilities

• Ensure the timely completion of high-quality robust investigations with appropriate root cause(s).
• Ensure appropriate Corrective and Preventative Actions (CAPA’s) are developed and implemented.
• Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of investigation closure and product release.
• Support regulatory inspections and audits by ensuring inspection readiness within facility and serving as an SME during the execution of regulatory inspections and audits as needed.
• 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 end-to-end manufacturing issues.
• Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
• Perform analysis on quality indicating data and identifying trends.
• Contribute to maintain investigation compliance metrics.
• Support investigation process improvement initiatives.
• Job duties performed may require exposure to and handling of biological materials and hazardous chemicals
• Able to work independently and also 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 2-4 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• Knowledge of cGMP and GDP regulations and FDA/EU guidance related to manufacture of cell based products
• 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.
• Excellent organizational skills with the ability to simplify and clearly communicate complex concepts.
• Excellent verbal, written and presentation capabilities.
• 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 communicate to management regarding complex issues.
• Ability to manage conflict and issues that arise with internal or external customers.

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