Qa Investigations Lead Jobs

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 Investigations Lead as part of the Quality team based in Raritan, NJ.

Role Overview

The QA Investigations Lead has the responsibilities 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

• Review and approve manufacturing procedures
• Perform internal housekeeping audits
• Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues
• Provide oversight for trending of quality compliance metrics
• Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints
• Perform analysis on quality indicating data and identifying trends
• Support regulatory inspections and audits by ensuring inspection readiness within facility
• Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs
• Work 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
• Good written and verbal communication skills are required
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision
• Ability to summarize and present results, and experience with team-based collaborations is a must
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices
• Ability to collaborate well with stakeholders, customers and peers
• Must exhibit strong leadership skills and effectively develop others
• Ability to manage conflict and issues that arise with internal or external customers
• Great attention to detail and ability to follow the procedures
• Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk
• 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
• 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

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.

Benefits:

• Paid Paternity Leave
• Flexible Spending Account
• Matched 401K
• Vision Insurance
• Pet Insurance
• Health Insurance
• Paid Maternity Leave
• Commuter Benefits
• Health Savings Account
• Life Insurance
• Hospital Indemnity Insurance
• AD&D Insurance
• Critical Illness Insurance
• Employee Assistance Program
• Legal Insurance
• Dental Insurance
• Long-Term Disability
• Accident Insurance
• Short-Term Disability