Manager, External Quality

Legend Biotech is seeking Manager, External Quality as part of the Global Quality team based in Somerset, NJ. 

Role Overview

The Manager of External Quality will support the implementation, maintenance, and continuous improvement of a global External Quality management program to support Global GMP, GTP and GDP operations and supply within Legend Biotech and ensure compliance with relevant regulations. The role is responsible for quality oversight of service providers used in the manufacture, package, test and distribution of Legend products. This includes hospitals, suppliers (including vectors), and apheresis centers.

Key Responsibilities  

• Support the External Quality management program:
  • Manage vendor quality management processes
  • Qualify key service providers, suppliers, and CMOs
  • Establish partnerships with key suppliers
  • Develop quality agreements with the suppliers.
• Serve as the Legend Biotech Quality point of contact and is responsible/accountable for the quality and compliance performance of the service providers, suppliers, and CMOs.
• Oversee the program to ensure change controls, deviations, complaints, CAPA, test methods, specification and improvement projects are managed in a compliant and timely manner.
• Approve all Vendor GMP documents impacting Legend Biotech product such as change controls, deviations, complaint investigations, CAPA, etc.
• Assess overall product quality performance, including identifying any product-specific quality and compliance risks and develop mitigation plans based on risk-based approach.
• Ensure the Annual Product Review/Product Quality Review reflects the operations performed by the vendor, provide the appropriate level of detail and required trend analysis.
• Work with Quality Auditing function to understand and mitigate any compliance risk and establish vendor quality scorecard.

• A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required. Advanced degree preferred.
• A minimum of 10 years relevant work experience is required.
• It is preferable that the candidate have experience working in and/or auditing aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Cell/Gene Therapy experience a plus.
• Understand/implement GMP, GDP and GTP requirements.
• Experience with direct management of personnel in a Quality Assurance role.
• Leader that can mentor and guide development of others.
• Demonstrated ability to interact with Global Health Authorities.
• Experience with partnering effectively with service providers, suppliers, and CMOs.
• Able to resolve global issues with demonstrative ability to provide innovative solutions.
• Strong written and verbal communication skills, and analytical problem solving and conflict resolutions kills.
• Flexible, highly motivated, with strong organization skills and the ability to multi-task. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Ability to work independently and to make decisions based on experience.
• Effective interpersonal skills. 

#LI-JK1-Justin