QA Investigator

Job Description

Legend Biotech is seeking a QA Investigator to provide quality oversight for the production of personalized cell therapies in a sterile GMP environment. This role supports both clinical and commercial requirements and involves collaborating with site personnel, maintaining manufacturing investigations, and managing cross-functional projects.Responsibilities include:

• Collaborating with site personnel to resolve manufacturing issues.
• Maintaining and reviewing manufacturing investigations, CAPAs, change controls, and complaints.
• Analyzing quality data and identifying trends.
• Managing cross-functional projects with many stakeholders.
• Ensuring compliance with safety policies, quality systems, and cGMP requirements.
• Providing guidance to other employees on quality issues.
• Driving continuous improvement.

Requirements:

• A minimum of a Bachelor’s Degree in Science, Information Science, or a related technical field.
• A minimum of 4 years of relevant work experience, preferably in an aseptic manufacturing facility.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing cell-based products.
• Strong interpersonal and written/oral communication skills.
• Proficiency in applying process excellence tools and methodologies.
• Detailed knowledge of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP).Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
• Language Requirements Dutch and technical English

Legend Biotech offers:

• The opportunity to work in a sterile GMP environment.
• Involvement in the production of personalized cell therapies.
• The chance to collaborate with various departments and stakeholders.