BioSpace
Director of Quality Operations
– BioSpace, Somerset, NJ
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. Legend Biotech entered into a global collaboration agreement with Janssen to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). The Director of Quality Operations will be integral to this mission.
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 develop and implement long‑term quality strategies, manage a team of QA professionals, and collaborate with cross‑functional counterparts to establish early phase clinical operations for Legend.
Key Responsibilities
Serve as the Quality Lead supporting cell therapy pipeline manufacturing operations at Somerset, NJ.
Build an exceptional QA team—hiring, mentoring, and developing personnel across Quality Assurance, Quality Systems, and Quality Control.
Ensure all processes, procedures, systems, and resources are in place for compliant disposition of materials and cell therapy products.
Collaborate with leaders across the organization to provide guidance and direction for clinical phase GMP operations and product lifecycle strategy.
Partner with internal and external Quality Heads to harmonize and align with quality policies, guidelines, programs, and systems.
Analyze regulatory authority programs relevant to advanced therapy products and advise site and Quality management of potential actions, exposures, and opportunities.
Establish and maintain effective partnerships with other business units, sites, and stakeholders to link business processes.
Perform tasks consistently with safety policies, quality systems, and cGMP requirements.
Implement a Quality Management review process.
Work collaboratively with Technical Development, Analytical Development, Manufacturing Operations, Engineering, Maintenance, Supply Chain, and Planning.
Handle any other duties as assigned.
Requirements
Bachelor’s Degree in Science, Information Science, or equivalent technical discipline.
Minimum 14 years of relevant experience, preferably in aseptic manufacturing, clinical quality, or cell therapy.
Knowledge of cGMP regulations, FDA/EU guidance for manufacturing cell‑based products, and Good Tissue Practices.
Strong interpersonal and written/oral communication skills.
Proven people management and leadership experience.
Experience with quality systems and ISO 5 clean room aseptic processing preferred.
Ability to process complex information and make critical decisions with limited data.
Ability to handle multiple priorities with flexibility and responsiveness.
Proficient in process excellence tools and Microsoft Office (Outlook, Excel, Word, PowerPoint).
Experience with ICH and/or 21 CFR parts 210, 211, 1271 (required) and 600, 601, 610 (preferred).
Good written, verbal, and presentation skills.
Compensation Base pay range: $187,989 – $246,735 USD.
Benefits We offer a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match; equity and stock options in eligible roles; eight weeks of paid parental leave after three months; paid time off including 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays; flexible spending and health savings accounts; life and AD&D insurance; short‑ and long‑term disability coverage; legal assistance; supplemental plans such as pet and critical illness; commuter benefits; family planning 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. Employment is at‑will and may be terminated at any time with or without cause or notice. 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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– BioSpace, Somerset, NJ
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. Legend Biotech entered into a global collaboration agreement with Janssen to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). The Director of Quality Operations will be integral to this mission.
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 develop and implement long‑term quality strategies, manage a team of QA professionals, and collaborate with cross‑functional counterparts to establish early phase clinical operations for Legend.
Key Responsibilities
Serve as the Quality Lead supporting cell therapy pipeline manufacturing operations at Somerset, NJ.
Build an exceptional QA team—hiring, mentoring, and developing personnel across Quality Assurance, Quality Systems, and Quality Control.
Ensure all processes, procedures, systems, and resources are in place for compliant disposition of materials and cell therapy products.
Collaborate with leaders across the organization to provide guidance and direction for clinical phase GMP operations and product lifecycle strategy.
Partner with internal and external Quality Heads to harmonize and align with quality policies, guidelines, programs, and systems.
Analyze regulatory authority programs relevant to advanced therapy products and advise site and Quality management of potential actions, exposures, and opportunities.
Establish and maintain effective partnerships with other business units, sites, and stakeholders to link business processes.
Perform tasks consistently with safety policies, quality systems, and cGMP requirements.
Implement a Quality Management review process.
Work collaboratively with Technical Development, Analytical Development, Manufacturing Operations, Engineering, Maintenance, Supply Chain, and Planning.
Handle any other duties as assigned.
Requirements
Bachelor’s Degree in Science, Information Science, or equivalent technical discipline.
Minimum 14 years of relevant experience, preferably in aseptic manufacturing, clinical quality, or cell therapy.
Knowledge of cGMP regulations, FDA/EU guidance for manufacturing cell‑based products, and Good Tissue Practices.
Strong interpersonal and written/oral communication skills.
Proven people management and leadership experience.
Experience with quality systems and ISO 5 clean room aseptic processing preferred.
Ability to process complex information and make critical decisions with limited data.
Ability to handle multiple priorities with flexibility and responsiveness.
Proficient in process excellence tools and Microsoft Office (Outlook, Excel, Word, PowerPoint).
Experience with ICH and/or 21 CFR parts 210, 211, 1271 (required) and 600, 601, 610 (preferred).
Good written, verbal, and presentation skills.
Compensation Base pay range: $187,989 – $246,735 USD.
Benefits We offer a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match; equity and stock options in eligible roles; eight weeks of paid parental leave after three months; paid time off including 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays; flexible spending and health savings accounts; life and AD&D insurance; short‑ and long‑term disability coverage; legal assistance; supplemental plans such as pet and critical illness; commuter benefits; family planning 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. Employment is at‑will and may be terminated at any time with or without cause or notice. 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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