GMP Senior Supervisor / Manager of Audits and Compliance

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 GMP Senior Supervisor / Manager of Audits and Compliance as part of the Quality team based in Somerset, NJ.

Role Overview

The GMP Senior Supervisor / Manager of Audits and Compliance role is responsible for the management of internal audits and external audits (domestic and international audits) in support of the internal and external audit program for Cell Therapy, ensuring Contract Development and Manufacturing Organizations (CDMOs), Material Suppliers, Equipment Suppliers, Service Providers and other suppliers are qualified. As a key member of Legend’s Quality team, the GMP Senior Supervisor / Manager of Audits and Compliance, will support the supplier qualification program, management of the suppliers’ approval status, internal audits, and inspection management program.

Scope of external audits includes but is not limited to CDMOs, laboratories, Apheresis collection and processing centers, raw and starting material suppliers, logistic / warehouse service providers, other materials, consumables and equipment suppliers, equipment service providers, etc. GMP Senior Supervisor / Manager of Audits and Compliance will support internal audits as part of the internal audit / self-inspection program. In addition, this role will support Compliance initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required.

Key Responsibilities

• Support the enhancement and Global harmonization of the supplier qualification program, including management of the electronic systems for this program.
• Manage and support the implementation of the internal and external audit program.
• Schedule, execute, report and follow-up on internal and US and Global external audits (travel required).
• Respect timelines for audit schedules, report writing / issuance, and follow-ups.
• Ensure audit observations are communicated, tracked, and remediated in compliance with internal policies and procedures as well as with all applicable regulatory requirements.
• Perform vendor risk assessments to determine and evaluate audit frequency.
• Assist with inspection readiness efforts and program implementation.
• Support continuous improvement efforts through the monitoring of audit metrics.
• Support GxP regulatory inspections as required.
• Assist with the development, maintenance and execution of the annual audit programs.
• Work with External Quality and other internal functions to understand and mitigate any compliance risk and establish vendor quality scorecard.
• Maintain auditing and supplier qualification procedures to support continuous improvement.
• Support development and gathering of quality metrics for Legend’s Quality Management Review (QMR).
• Support management of the Quality Management Review (QMR) program.
• Support Legend’s regulatory program and monitor the regulatory landscape to stay informed of regulatory trends and developments.
• Support the development of the GMP Compliance program related to clinical/ commercial stage and manufacturing.
• Support the Compliance and Auditing team for any improvement process.
  
  
  

Requirements

• A minimum of a Bachelor’s degree in Science, Engineering or equivalent technical discipline. Advanced degree preferred.
• 10 years of relevant work experience within a pharmaceutical / biotech industry is required. A Minimum 4 years of auditing experience is also required.
• Experience with collaborating and communicating effectively with service providers, suppliers, and CMO/CDMOs
• Highly motivated, flexible, and excellent organizational skills
• Experienced working in Quality Assurance, Quality Systems and/or Quality Operations
• Strong knowledge of global GxP regulations (US is a must; EU, China and GTP are considered a plus)
• Excellent verbal and written communication skills
• Ability to prioritize and balance work from multiple projects in parallel
• Knowledge of Cell therapy regulations and field audit experience considered a plus
• Regulatory Agencies first hand inspection experience considered a plus
• Clinical and GLP audit experience considered a plus
  
  
  

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:

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