Current jobs related to Quality Compliance Lead - Raritan, New Jersey - Legend Biotech Corp

  • Quality Compliance Lead

    2 weeks ago

    Raritan, New Jersey, United States Legend Biotech US Full time

    Job Title: Quality Compliance LeadLegend Biotech US is seeking a Quality Compliance Lead to join our Quality team based in Raritan, NJ.Job SummaryThe Quality Compliance Lead will be responsible for regulatory compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom...

  • Quality Compliance Lead

    1 week ago

    Raritan, New Jersey, United States Legend Biotech US Full time

    Job SummaryThe Quality Compliance Lead will be responsible for ensuring regulatory compliance in the production of autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment. This role will support the implementation, execution, and improvement of the internal audit process, as well as coordinate front...

  • Regulatory Compliance Lead

    1 week ago

    Raritan, New Jersey, United States Katalyst Healthcares and Life Sciences Full time

    Job Description:As a Regulatory Compliance Lead, you will be responsible for ensuring that all computerized systems used in the manufacturing process of Katalyst Healthcares and Life Sciences meet the strict regulatory requirements of the FDA and EU. Your expertise in Computer System Validation (CSV) and quality management will be crucial in maintaining our...

  • Quality Assurance Document Control Lead

    3 weeks ago

    Raritan, New Jersey, United States Legend Biotech US Full time

    Job Title: QA Document Control LeadLegend Biotech US is seeking a highly skilled QA Document Control Lead to join our Quality team based in Rarita, NJ.Job Summary:The QA Document Control Lead will be responsible for supporting the document management process within a cell therapy manufacturing facility to meet both clinical and commercial requirements in a...

  • Regulatory Compliance Specialist

    3 weeks ago

    Raritan, New Jersey, United States Katalyst Healthcares and Life Sciences Full time

    Job Title: CSV SpecialistKatalyst Healthcares and Life Sciences is seeking a highly skilled CSV Specialist to join our team.Responsibilities:Provide leadership and oversight to project teams in the area of Computer System Validation, ensuring compliance with regulatory requirements.Ensure the quality oversight of GxP regulated computerized systems, including...

  • Quality Assurance Supervisor

    2 weeks ago

    Raritan, New Jersey, United States Legend Biotech US Full time

    Quality Assurance SupervisorLegend Biotech US is seeking a Quality Assurance Supervisor to provide quality oversight over the production of a personalized cell therapy in a sterile GMP environment. The successful candidate will have a minimum of 5 years of relevant work experience and a Bachelor's Degree in Science, Engineering, or equivalent technical...

  • Regulatory Compliance Specialist

    2 weeks ago

    Raritan, New Jersey, United States Eateam Full time

    Key Responsibilities:* Develop and execute validation plans for FDA and Global regulated environments.* Ensure compliance with GxP standards and industry guidelines (e.g., GAMP).* Collaborate with cross-functional teams to design and implement validation strategies.* Create and review documentation for validation deliverables, including requirements,...

  • Senior Specialist, Quality Systems

    2 weeks ago

    Raritan, New Jersey, United States J&J Family of Companies Full time

    Job Title: Senior Specialist, Quality SystemsJob Summary:We are seeking a highly skilled Senior Specialist, Quality Systems to join our team at J&J Family of Companies. As a Senior Specialist, Quality Systems, you will be responsible for independently performing Quality Systems activities, identifying issues, and implementing resolutions. You will assess...

  • Senior Manager of Quality Management Systems

    2 weeks ago

    Raritan, New Jersey, United States Johnson and Johnson Full time

    Job SummaryJohnson & Johnson is seeking a Senior Manager of Quality Management Systems to oversee the operations of the company's Technology Services QMS. This role will be responsible for ensuring the highest standards of quality and compliance, and will work closely with the Director of the QMS to establish and maintain quality assurance standards.Key...

  • Senior Manager of Quality Management Systems

    2 weeks ago

    Raritan, New Jersey, United States Johnson and Johnson Full time

    Johnson & Johnson is seeking a Senior Manager of Quality Management Systems to oversee the operations of the company's Technology Services QMS. This role will be responsible for ensuring the quality system is flawless, world-class, and adheres to GxP requirements and ISO regulations.The ideal candidate will have 8-10 years of progressive experience in the...

  • Senior Quality Project Manager

    2 weeks ago

    Raritan, New Jersey, United States Legend Biotech US Full time

    Job Title: Associate Director of Quality Project Management and StrategyLegend Biotech US is seeking an experienced Associate Director of Quality Project Management and Strategy to join our Quality team based in Raritan, NJ.Role OverviewThe Associate Director of Quality Project Management and Strategy will provide quality oversight over process improvement...

  • Cytology Team Lead

    2 months ago

    Raritan, New Jersey, United States LCH Lab. Corp. of America Holdings Full time

    Job SummaryWe are seeking a highly skilled Cytotechnologist to fill the role of Team Lead in our Raritan, NJ laboratory. As a key member of our team, you will be responsible for overseeing the daily operations of the cytology laboratory, ensuring the highest level of quality and accuracy in our testing and reporting.Key ResponsibilitiesAssist with data...

  • Cytology Team Lead

    1 month ago

    Raritan, New Jersey, United States LabCorp Full time

    Job SummaryWe are seeking a highly skilled Cytotechnologist to join our team as a Team Lead in Raritan, NJ. As a Cytotechnologist Team Lead, you will be responsible for overseeing the daily operations of the cytology laboratory, ensuring the highest quality of patient care, and maintaining a fast-paced and customer-focused environment.Key...

  • Quality Assurance Engineer

    2 weeks ago

    Raritan, New Jersey, United States Disability Solutions Full time

    Job SummaryThe Quality Assurance Engineer will play a key role in ensuring the highest quality experiences for our patients and customers. This position will be responsible for supporting Quality Engineering activities related to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the Wound Closure and Healing (WCH)...

  • Senior Quality Systems Specialist

    1 week ago

    Raritan, New Jersey, United States J&J Family of Companies Full time

    Job Summary:We are seeking a highly skilled Senior Quality Systems Specialist to join our team at J&J Family of Companies. As a key member of our Quality Systems team, you will be responsible for independently performing Quality Systems activities, identifying issues, and implementing resolutions. You will assess data and prepare and review documentation to...

  • Senior Quality Systems Specialist

    1 week ago

    Raritan, New Jersey, United States J&J Family of Companies Full time

    Job Summary: We are seeking a highly skilled Senior Quality Systems Specialist to join our team at Janssen Pharmaceuticals, Inc., a member of the J&J Family of Companies. The successful candidate will be responsible for independently performing Quality Systems activities, identifying issues, and implementing resolutions.Key Responsibilities:Perform Quality...

  • QC Supervisor

    2 weeks ago

    Raritan, New Jersey, United States Legend Biotech US Full time

    Job DescriptionLegend Biotech US is seeking a highly skilled QC Supervisor to join our Quality Operations team. As a key member of our team, you will be responsible for supervising the operation and workflow of the quality control laboratories in support of cell therapy manufacturing.Key ResponsibilitiesTraining and Development: Ensure adequate training of...

  • Senior Specialist, Quality Systems

    2 weeks ago

    Raritan, New Jersey, United States Johnson and Johnson Full time

    We are seeking a highly skilled Quality Systems Specialist to join our team at Johnson & Johnson. In this role, you will independently perform Quality Systems activities, identify issues, and implement resolutions, assess data, and independently prepare and review documentation.Key Responsibilities:Provide support and robust guidance for Quality Systems,...

  • Quality Assurance Engineer

    4 weeks ago

    Raritan, New Jersey, United States J&J Family of Companies Full time

    Job SummaryThe Quality Engineer Co-Op will play a key role in ensuring the highest quality experiences for our patients and customers. This position will support Quality Engineering activities related to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the Wound Closure and Healing (WCH) or the Biosurgery...

  • Lead Infant Teacher

    2 weeks ago

    Raritan, New Jersey, United States The Learning Gate Full time

    Job DescriptionAt The Learning Gate, we are seeking a highly skilled and dedicated Lead Infant Teacher to join our team. This is a unique opportunity to make a positive impact on the lives of young children and their families.Key Responsibilities:Supervise and manage the Waddler Classroom, ensuring a safe and nurturing environment for all children.Develop...

Quality Compliance Lead

2 months ago

Raritan, New Jersey, United States Legend Biotech Corp Full time
{"Role Overview": "

The Quality Compliance Lead is responsible for ensuring the company's compliance with regulatory requirements and industry standards in the production of autologous CAR-T products for clinical trials and commercial operations.

", "Key Responsibilities": "
  • Implement and execute the internal audit process to ensure compliance with regulatory requirements and industry standards.
  • Plan and execute internal audits for all quality system areas, write audit reports, and follow-through to ensure satisfactory resolution and closure of each internal audit.
  • Coordinate front room/back room activities for health authority audits and independent audits, manage audit responses, and observation resolution.
  • Drive site compliance to regulatory, enterprise, and global requirements through building positive relationships across functions to meet unified business objectives.
  • Run reports and conduct data analysis to support monitoring of key performance indicators, and support the preparation of compliance data for the monthly CRB & quarterly QSMR presentations.
  • Fulfill the Quality System audit module site key user responsibilities, represent the Raritan site in global forums/team meetings, mentor site users for audit process, and control access to any systems used to support audits/inspections.
  • Provide support to quality systems team, ad hoc, for activities such as annual product review, site risk register, or internal quality agreements.
  • Develops and delivers training for specific quality system topics, in both classroom setting and individual interactions.
  • Support the creation, assessment, and closure as needed of corrective actions, change controls, or audit actions related to the site.
  • Ensure and maintain a state of inspection readiness.
  • Perform compliance walkthroughs as part of audit/inspection readiness activities to ensure that the site is an inspection-ready state.
  • Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
", "Requirements": "
  • A minimum of a Bachelor's Degree in Engineering, Science, or equivalent technical discipline is required.
  • A minimum of six (6) years of experience in Quality Assurance/Quality Systems or Compliance with a minimum of 4 of those within laboratories or laboratory oversight.
  • Experience conducting internal audits (self-inspection), including writing audit reports, writing observations, and follow-through of observation resolution.
  • Experience in front room/back room roles for external audits.
  • Experience working with quality systems is required.
", "Company Overview": "

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 and natural killer (NK) cell-based immunotherapy.

", "About Us": "

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autoleucel (cilta-cel) in 2017. 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.

", "Equal Opportunity Employer": "

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 law.

", "Drug-Free Workplace": "

Legend Biotech maintains a drug-free workplace.

", "Contact Us": "

Please note that we do not accept unsolicited resumes or applications. If you are interested in joining our team, please visit our website for available positions and application instructions.

", "Disclaimer": "

The information contained in this job description is accurate at the time of posting and may be subject to change.

", "Job Type": "Full-time"}