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 are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

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). 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 a Senior Director of Quality Operations as part of the Quality team based in Raritan, NJ.

Role Overview

The Sr. Director of Quality will lead Legend CAR-T manufacturing facilities within the United States and ensure the sites operate in full compliance with established cGMP requirements. This individual will be a key leader in the Global Cell Therapy Quality organization and a champion for quality principles and compliance.  The role develops and implements long-term strategies and execution of Quality programs across the sites. This role will also manage a team of people leaders and technical professionals within the QA department based on assigned work, direction, coaching and developing capabilities. The Sr. Director will collaborate with external counterparts to develop and establish transition activities and responsibilities for Legend.

Key Responsibilities

• Serves as the Quality Lead in support of cell therapy manufacturing and operations within the United States.
• Provide leadership and build an exceptional team to manage the Quality functions (Quality Assurance, Quality Systems, Quality Control), including hiring, mentoring and developing personnel.
• Assure the required processes, procedures, systems and resources are in place to ensure a compliant disposition of materials and cell therapy products.
• Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management system, including providing guidance and direction for transitioning from clinical to commercial phase GMP operations.
• Partners with other 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 and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
• Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility.
• Establishes effective partnerships with other business units, sites, and individuals to ensure business processes are effectively linked.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Other duties will be assigned, as necessary. 

Requirements

• A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
• A minimum of 16 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably 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 as well as knowledge of Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Proven people management and leadership experience is required.
• Experience working with quality systems is required.
• Extensive knowledge of chemical, biochemical and microbiological concepts is required.
• Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
• Proficient in applying process excellence tools and methodologies.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude.
• Good written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Experience developing and setting long-term objectives.
• 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.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint). 

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Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.