Legend Biotech US
Specialist, QA Process Excellence
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.
Role Overview The QA Process Excellence Specialist III role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role also provides oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities.
Key Responsibilities
Provide quality oversight and technical expertise to the Technical Operations and Manufacturing Teams.
Guide industry best practices and quality requirements for maintaining a compliant manufacturing state.
Investigate and resolve deviations during routine manufacturing and protocol‑driven activities such as tech transfer and process validation.
Assist in developing process, operational, and quality improvements for manufacturing.
Review and develop process‑related protocols and documentation.
Oversee electronic batch records, change controls, SOPs, CAPAs, and non‑conformances.
Trouble‑shoot and resolve complex scientific and technical problems.
Evaluate quality processes and system standards to ensure compliance with internal and industry standards.
Handle multiple priorities daily while being flexible and responsive to shifting priorities.
Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
Support CSV activities and equipment qualification activities as needed.
Requirements
Minimum Bachelor’s Degree in Science or equivalent technical discipline.
5+ years relevant experience with at least 5 years of quality assurance experience in an aseptic manufacturing facility, preferably in cell therapy.
Strong knowledge of cell therapy processes strongly preferred.
Experience with Manufacturing Execution Systems (MES) design, development, and validation preferred.
Experience with Computer System Validation (CSV) a plus.
Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals.
Experience reviewing and auditing GMP documentation.
Strong interpersonal and written/oral communication skills.
Detail‑oriented, highly organized, and able to work independently and collaboratively.
Proficiency with Microsoft Office applications.
Salary $75,972 – $99,713 USD
Benefits Legend Biotech offers 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 that vests fully on day one; equity and stock options for eligible roles; eight weeks of paid parental leave after three months of employment; a paid time off policy with 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, 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. We provide 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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Role Overview The QA Process Excellence Specialist III role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role also provides oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities.
Key Responsibilities
Provide quality oversight and technical expertise to the Technical Operations and Manufacturing Teams.
Guide industry best practices and quality requirements for maintaining a compliant manufacturing state.
Investigate and resolve deviations during routine manufacturing and protocol‑driven activities such as tech transfer and process validation.
Assist in developing process, operational, and quality improvements for manufacturing.
Review and develop process‑related protocols and documentation.
Oversee electronic batch records, change controls, SOPs, CAPAs, and non‑conformances.
Trouble‑shoot and resolve complex scientific and technical problems.
Evaluate quality processes and system standards to ensure compliance with internal and industry standards.
Handle multiple priorities daily while being flexible and responsive to shifting priorities.
Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
Support CSV activities and equipment qualification activities as needed.
Requirements
Minimum Bachelor’s Degree in Science or equivalent technical discipline.
5+ years relevant experience with at least 5 years of quality assurance experience in an aseptic manufacturing facility, preferably in cell therapy.
Strong knowledge of cell therapy processes strongly preferred.
Experience with Manufacturing Execution Systems (MES) design, development, and validation preferred.
Experience with Computer System Validation (CSV) a plus.
Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals.
Experience reviewing and auditing GMP documentation.
Strong interpersonal and written/oral communication skills.
Detail‑oriented, highly organized, and able to work independently and collaboratively.
Proficiency with Microsoft Office applications.
Salary $75,972 – $99,713 USD
Benefits Legend Biotech offers 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 that vests fully on day one; equity and stock options for eligible roles; eight weeks of paid parental leave after three months of employment; a paid time off policy with 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, 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. We provide 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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