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 Director of Quality Operations as part of the Quality team based in Somerset, NJ.

Role Overview

The Director of Quality Operations will lead the internal Legend cell therapy manufacturing facility at Somerset, NJ and ensure the site operates in full compliance with established cGMP clinical requirements. This individual will be a key leader in the US Operations organization and a champion for quality principles and compliance. The role develops and implements long-term quality strategies and execution for the internal Legend clinical manufacturing facility. 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 Director will collaborate with cross-functional counterparts to develop and establish early phase clinical operations for Legend.

Key Responsibilities

Serves as the Quality Lead in support of cell therapy pipeline manufacturing operations at Somerset, NJ
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 for product life cycle strategy and management of GXP policies and quality management system, including providing guidance and direction for clinical phase GMP operations.
Partners with other internal and external Quality Heads to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems.
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.
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.
Establish and implement a Quality Management review process.
Works in a collaborative team setting with quality counterparts that include Technical Development, Analytical Development, Manufacturing Operations, Engineering and Maintenance, Supply Chain and Planning.
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 14 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).

The anticipated base pay range is: $187,989 USD - $246,735 USD

Benefits

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

EEO Statement

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.

Legend Biotech maintains a drug-free workplace.

Benefits:

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Matched 401K
Flexible Spending Account
Health Savings Account
AD&D Insurance
Short-Term Disability
Long-Term Disability
Paid Maternity Leave
Paid Paternity Leave
Pet Insurance
Critical Illness Insurance
Hospital Indemnity Insurance
Accident Insurance
Legal Insurance
Commuter Benefits
Employee Assistance Program

Legend Biotech

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