Senior Director of Quality Operations

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across diverse platforms, including autologous and allogenic CAR‑T, TCR‑T, and NK cell‑based immunotherapy. From our three R&D sites worldwide, we apply innovative technologies to discover safe, efficacious, cutting‑edge therapeutics for patients globally.

Legend Biotech entered into a global collaboration agreement with Janssen, a subsidiary of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecel (cilta‑cel). Our partnership combines expertise to advance an immunotherapy for multiple myeloma.

The Sr. Director of Quality will lead Legend CAR‑T manufacturing facilities in the United States and ensure full compliance with cGMP requirements. This key leader in the Global Cell Therapy Quality organization champions quality principles and compliance, develops and implements long‑term strategies and executes Quality programs across sites. The role manages a team of people leaders and technical professionals within QA, provides direction, coaching, and capability development, and collaborates with external counterparts to establish transition activities and responsibilities for Legend.

• Serves as the Quality Lead supporting cell therapy manufacturing and operations in the United States.
• Builds an exceptional team to manage Quality functions (Quality Assurance, Quality Systems, Quality Control), including hiring, mentoring, and developing personnel.
• Assures the required processes, procedures, systems, and resources are in place for compliant disposition of materials and cell therapy products.
• Collaborates with leaders across the organization to continuously improve and manage GMP policies and the quality management system, including guidance for transitioning from clinical to commercial GMP operations.
• Partners with internal and external Quality Heads to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems.
• Proactively develops and sustains strong relationships with local/ regional/national regulatory authorities.
• Analyzes regulatory authorities’ programs and activities in areas relevant to advanced therapy products and advises site and Quality management of potential actions that could adversely affect the business.
• Evaluates the functional strengths and developmental areas of the Quality organization and focuses on continuous improvement for organizational agility.
• Establishes effective partnerships with other business units, sites, and individuals to ensure business processes are effectively linked.
• Performs tasks in line with safety policies, quality systems and cGMP requirements.
• Other duties as assigned.

• A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline.
• A minimum of 16 years relevant work experience, preferably in an aseptic manufacturing facility with experience in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products and Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Proven people management and leadership experience.
• Experience working with quality systems.
• Extensive knowledge of chemical, biochemical and microbiological concepts.
• Experience with aseptic processing in ISO 5 clean room and biosafety cabinets (preferred).
• Ability to process complex information quickly and make critical decisions with limited information.
• Ability to handle multiple priorities daily while being flexible and responsive to shifting priorities.
• Proficient in applying process‑excellence tools and methodologies.
• Highly organized and capable of working in a team environment with a positive attitude.
• Good written and verbal communication skills.
• Ability to summarize and present results; experience with team‑based collaborations.
• Experience developing and setting long‑term objectives.
• Ability to identify and remediate gaps in processes or…