QA Investigator

**Company Information**

Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.

**Role Overview**:
The **QA Investigator** 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 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 compliant product supply.

**Major Responsibilities**:

- Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues.
- Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
- Perform analysis on quality indicating data and identifying trends.
- Collaborates with functional departments to resolve issues.
- Manage cross-functional projects with many stakeholders.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Require mínimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with manager for decisions outside established processes.
- Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
- Routinely recognize and resolve quality issues. Seek management guidance on complex issues.
- Drive continuous improvement.

**Qualifications**

**Education**:
A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required.

**Experience**:
**Key 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.
- Strong interpersonal and written/oral communication skills.
- Ability to quickly process complex information and often make critical decisions with limited information.
- Ability to pay attention to details and follow the procedures.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a requirement.
- Ability to work with others in a team environment.
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
- Ability to identify/remediate gaps in processes or systems.
- Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.

**Language Requirements**

Dutch and technical English

LI-AG1

Legend Biotech maintains a drug-free workplace.