QA Investigator Supervisor

Job content

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.

Role Overview

The QA Investigator Supervisor is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in an aseptic GMP environment.

This includes hiring, development and performance management of staff, reviewing/approving operational procedures, supporting and approving manufacturing investigations and ownership of various department projects. She/he will be responsible for multiple work centers within the facilities including tracking of quality metrics while ensuring high quality and compliant product supply.

This role will provide direct leadership to QA Investigators (Quality Leaders) for managing deviations/investigations, and monitoring Quality metrics.

Major Responsibilities:

• Supervise a team of QA Investigators.
• Responsible for onboarding and training of QA Investigators.
• Provide guidance to the QA Investigators (Quality Leaders) about handling the various non-conformances.
• Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
• Support the QA Investigators in meetings with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning.
• Perform timely escalations of potential significant quality issues to management.
• Escalate to management about issues delaying product release or investigation closure.
• Review and approve critical level investigations and supporting corrections and CAPAs.
• Lead continuous improvement associated with investigation management.
• Provide oversight for execution of internal housekeeping audits.
• Provide oversight for trending of quality compliance metrics.
• Review and approve manufacturing procedures.
• Support all activities for site Quality Operations in accordance with Legend and Janssen (where applicable) standards, procedures and cGMPs.
• Support regulatory inspections and audits by ensuring inspection readiness within facility.
• Other duties will be assigned, as necessary.
  
  

Qualification

Education:

A minimum of a Master Degree in Pharmaceutical/Biological/Biochemical Science/Bio engineering related or equivalent technical discipline is required.

Experience:

A minimum of 5 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. A minimum of 2 years of leadership experience is also required.

Capabilities, Knowledge, and skills:

• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
• Knowledge of Nonconformance and CAPA management process
• Leadership, project and people management skills
• 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, partners, 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.
• Great attention to detail and ability to follow the procedures.
  
  

Language(s):

Dutch & Technical English

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 law.

Legend Biotech maintains a drug-free workplace.