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Director of Quality Operations
role at
BioSpace .
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 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.
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 and will also manage a team of people leaders and technical professionals within the QA department based on assigned work, direction, coaching and development of capabilities.
Key Responsibilities
Serve as the Quality Lead in support of cell therapy clinical manufacturing 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 the quality management system, including providing guidance and direction for clinical phase GMP operations.
Partner with other internal and external Quality Heads to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems.
Analyze regulatory authorities’ programs and activities in areas relevant to advanced therapy products and advise site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures or pursue opportunities.
Establish 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.
Work in a collaborative team setting with quality counterparts that include Technical Development, Analytical Development, Manufacturing Operations, Engineering and Maintenance, Supply Chain and Planning.
Requirements
A minimum of a Bachelor’s Degree in Science, Information Science or an equivalent technical discipline.
A minimum of 14 years relevant work experience; preference for experience 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 manufacture of cell‑based products, as well as Good Tissue Practices.
Strong interpersonal, written and 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 rooms and biosafety cabinets (preferred).
Ability to quickly process complex information and make critical decisions with limited information.
Ability to handle multiple priorities on a daily basis while remaining flexible and responsive to shifting priorities.
Proficiency in applying process‑excellence tools and methodologies.
Highly organized and able to work in a team environment with a positive attitude.
Good written and verbal communication skills.
Ability to summarize and present results, and experience with team‑based collaborations.
Experience developing and setting long‑term objectives.
Ability to identify and remediate gaps in processes or systems.
Experience with ICH and/or 21 CFR parts 210, 211, 1271 (required) and 600, 601, 610 (preferred).
Proficiency with Microsoft Office applications (Outlook, Excel, Word, PowerPoint).
The anticipated base pay range is $187,989 – $246,735 USD.
Benefits We are committed to creating a workplace where employees can thrive – both professionally and personally. Our best‑in‑class benefits package supports well‑being, financial stability, and long‑term career growth, including medical, dental, and vision insurance, a 401(k) retirement plan with company match that vests fully on day one, equity and stock options for eligible roles, eight weeks of paid parental leave after three months of employment, 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and HSA accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance, commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs.
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. Legend’s policy ensures 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.
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Director of Quality Operations
role at
BioSpace .
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 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.
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 and will also manage a team of people leaders and technical professionals within the QA department based on assigned work, direction, coaching and development of capabilities.
Key Responsibilities
Serve as the Quality Lead in support of cell therapy clinical manufacturing 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 the quality management system, including providing guidance and direction for clinical phase GMP operations.
Partner with other internal and external Quality Heads to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems.
Analyze regulatory authorities’ programs and activities in areas relevant to advanced therapy products and advise site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures or pursue opportunities.
Establish 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.
Work in a collaborative team setting with quality counterparts that include Technical Development, Analytical Development, Manufacturing Operations, Engineering and Maintenance, Supply Chain and Planning.
Requirements
A minimum of a Bachelor’s Degree in Science, Information Science or an equivalent technical discipline.
A minimum of 14 years relevant work experience; preference for experience 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 manufacture of cell‑based products, as well as Good Tissue Practices.
Strong interpersonal, written and 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 rooms and biosafety cabinets (preferred).
Ability to quickly process complex information and make critical decisions with limited information.
Ability to handle multiple priorities on a daily basis while remaining flexible and responsive to shifting priorities.
Proficiency in applying process‑excellence tools and methodologies.
Highly organized and able to work in a team environment with a positive attitude.
Good written and verbal communication skills.
Ability to summarize and present results, and experience with team‑based collaborations.
Experience developing and setting long‑term objectives.
Ability to identify and remediate gaps in processes or systems.
Experience with ICH and/or 21 CFR parts 210, 211, 1271 (required) and 600, 601, 610 (preferred).
Proficiency with Microsoft Office applications (Outlook, Excel, Word, PowerPoint).
The anticipated base pay range is $187,989 – $246,735 USD.
Benefits We are committed to creating a workplace where employees can thrive – both professionally and personally. Our best‑in‑class benefits package supports well‑being, financial stability, and long‑term career growth, including medical, dental, and vision insurance, a 401(k) retirement plan with company match that vests fully on day one, equity and stock options for eligible roles, eight weeks of paid parental leave after three months of employment, 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and HSA accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance, commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs.
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. Legend’s policy ensures 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.
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