Manager / Sr Manager of Quality Assurance and Compliance

6 days ago


Somerset, New Jersey, United States Legend Biotech US Full time
Job Summary

Legend Biotech US is seeking a highly skilled Manager/Sr. Manager, Quality Assurance and Compliance to join our Regulatory team in Somerset, NJ. As a key member of our team, you will be responsible for ensuring the quality and compliance of our nonclinical studies, maintaining a compliant quality system, and overseeing laboratory processes.

Key Responsibilities
  • Quality Compliance Systems: Support the implementation and maintenance of quality policies and procedures for the Quality Assurance function.
  • GLP Quality Systems: Manage GLP quality systems, including audits and reviews to ensure compliance.
  • Deviations and Audits: Support the process of deviations from study protocols or standard operating procedures, and conduct internal and external GLP study audits.
  • Quality Oversight: Provide quality oversight of contract or internal testing facilities to ensure adherence to regulations and standard procedures.
  • Documentation and Communication: Develop and review quality-related documentation, and communicate activities and feedback to the Quality management team.
Requirements
  • Education: Bachelor's degree in biology, biochemistry, or the life sciences.
  • Communication Skills: Must be able to communicate effectively in English.
  • Industry Experience: A minimum of 3 years (for Sr. Manager) or 1 year (for Manager level) of related industry experience in Quality Assurance.
  • GLP Experience: 3 years of experience in working and/or overseeing GLP Quality in laboratories testing biologics.
  • Audit Experience: Experience performing audits of GLP testing labs and participating in and hosting regulatory audits.
  • Project Management: Strong project management skills and ability to articulate QA-GLP perspective at cross-functional meetings.
  • Regulatory Knowledge: Working knowledge of relevant FDA, ICH GCP guidelines, and GCP, GLP related regulations.
What We Offer

Legend Biotech US is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



  • Somerset, New Jersey, United States Syneos Health inVentiv Health Commercial LLC Full time

    Position OverviewThe Senior Manager, Quality Assurance in Commercial Operations is a seasoned quality professional within the life sciences and healthcare sectors, tasked with enhancing and sustaining a robust Quality Management System (QMS) for the Commercial segment of the organization. This role is pivotal in driving significant quality initiatives,...


  • Somerset, New Jersey, United States Legend Biotech US Full time

    Job SummaryLegend Biotech US is seeking a highly skilled Quality Assurance Manager / Sr Manager of GLP-CQA to join our Regulatory team based in Somerset, NJ. The successful candidate will be responsible for ensuring compliance with GLP regulations and Health Authorities' guidance/principles.Key ResponsibilitiesDevelop and maintain a compliant quality system...


  • Somerset, New Jersey, United States PIM Brands , LLC Defunct Full time

    Job OverviewWe are seeking a dedicated Quality Control Inspector to join our Quality Assurance team. This role is essential in ensuring that our products meet the highest standards of quality and safety. Job LocationSomerset - Somerset, NJPosition TypeFull TimeJob CategoryQA - Quality ControlKey ResponsibilitiesConduct routine inspections and testing of...


  • Somerset, New Jersey, United States LanceSoft, Inc. Full time

    Position: Quality Assurance EngineerLocation: RemoteDuration: ContractShift: Standard Business HoursRole Overview:We are looking for a skilled Quality Assurance Engineer to enhance our quality engineering practices. This role is crucial in ensuring that our products meet the highest standards of quality and reliability. As a key contributor, you will work...


  • Somerset, New Jersey, United States Omni Inclusive Full time

    Position: Manual QA TesterOverview:We are seeking a skilled Manual QA Tester who is proficient in writing SQL queries. The ideal candidate will have a strong background in software quality assurance and a passion for ensuring high-quality software products.Key Responsibilities:Conduct thorough testing of software applications to identify defects and ensure...


  • Somerset, New Jersey, United States Terumo Full time

    Terumo Medical Corporation (TMC) is at the forefront of developing, producing, and distributing a comprehensive range of high-quality medical devices that cater to various sectors within the healthcare industry. Our commitment lies in delivering exceptional products, alongside robust training and educational programs that yield significant economic benefits,...


  • Somerset, New Jersey, United States Omni Inclusive Full time

    Position: Manual QA TesterOverview:We are seeking a dedicated Manual QA Tester who possesses strong SQL query writing skills. The ideal candidate will have a robust skill set in software quality assurance and a passion for ensuring high-quality software products.Key Responsibilities:Conduct thorough testing of software applications to identify defects and...

  • Validation Engineer

    4 days ago


    Somerset, New Jersey, United States System One Holdings, LLC Full time

    About the Role:We are seeking a highly skilled Validation Engineer to join our team at System One Holdings, LLC. As a key member of our Quality Assurance department, you will be responsible for ensuring the validation of our manufacturing processes and equipment.Key Responsibilities:Validation Protocol Development: Develop and implement validation protocols,...


  • Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Position Overview:The Healthcare Compliance Specialist plays a crucial role in assisting the Director of Healthcare Compliance with various departmental projects aimed at fostering the development and execution of the Company Ethics and Compliance Program within the designated Terumo division(s).Key Responsibilities:1. Collaborate with the Director to...


  • Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Position Overview:The Healthcare Compliance Manager plays a crucial role in assisting the Director of Healthcare Compliance with various departmental projects aimed at enhancing and executing the Company's Ethics and Compliance Program within the designated Terumo division(s).Key Responsibilities:- Collaborate with the Director to develop compliance...


  • Somerset, New Jersey, United States smart techlink Full time

    Job OverviewWe are seeking a skilled Manual QA Tester to join our dynamic team. The ideal candidate will possess a strong background in software quality assurance and a passion for ensuring the highest quality in software products.Key ResponsibilitiesConduct thorough manual testing of software applications to identify defects and ensure quality...


  • Somerset, New Jersey, United States smart techlink Full time

    Job OverviewWe are seeking a dedicated Manual QA Tester to join our team. The ideal candidate will possess a strong background in software quality assurance and a passion for ensuring the highest quality in software products.Key ResponsibilitiesThe Manual QA Tester will be responsible for:Conducting thorough manual testing of software applications to...


  • Somerset, New Jersey, United States Eateam Full time

    Job OverviewWe are seeking a dedicated Mobile Quality Assurance Engineer to join our team at Eateam. The ideal candidate will play a crucial role in ensuring the quality and performance of our mobile applications and systems.Key ResponsibilitiesDevelop and implement testing scripts based on feature outlines, user stories, and design specifications.Create and...


  • Somerset, New Jersey, United States IMS People Full time

    Job OverviewPosition: Regulatory Compliance AnalystLocation: Not specifiedDuration: Not specifiedShift: Not specifiedRole Summary:The Regulatory Compliance Analyst is expected to possess extensive knowledge of international regulations relevant to the pharmaceutical sector and their implications on production methodologies. The ideal candidate should be...


  • Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Job Summary:The Healthcare Compliance Manager supports the Director of Healthcare Compliance in driving departmental initiatives to develop and implement the Company's Ethics and Compliance Program across assigned Terumo Medical Corporation divisions.Key Responsibilities:Collaborate with the Director of Healthcare Compliance to develop and implement the...


  • Somerset, New Jersey, United States L Oreal USA Full time

    About the RoleWe are seeking a highly skilled Environmental Sustainability Manager to join our team at L'Oreal USA. As a key member of our operations team, you will play a critical role in supporting our plant in planning, coordinating, and implementing environmental compliance and sustainability initiatives.Key ResponsibilitiesEnvironmental Compliance...


  • Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Position Overview:The Regulatory Compliance Specialist will assess the existing regulatory frameworks and devise strategies for Terumo's medical devices and initiatives, ensuring adherence to necessary regulations. The complexity of this role will fluctuate based on the scope of projects and the various regulatory environments involved. This position is...


  • Somerset, New Jersey, United States System One Holdings, LLC Full time

    Job SummaryWe are seeking a highly skilled Validation Specialist to join our team at System One Holdings, LLC. As a key member of our Quality Assurance department, you will be responsible for ensuring the accuracy and reliability of our manufacturing processes.Key ResponsibilitiesDevelop and Implement Validation ProtocolsDesign and execute Installation...


  • Somerset, New Jersey, United States System One Holdings, LLC Full time

    Job SummaryWe are seeking a highly skilled Validation Specialist to join our team at System One Holdings, LLC. As a key member of our Quality Assurance department, you will be responsible for ensuring the accuracy and reliability of our products.Key ResponsibilitiesDevelop and Implement Validation ProtocolsDesign and execute Installation Qualification (IQ),...


  • Somerset, New Jersey, United States Terumo Medical Corporation Full time

    Position Overview:The Regulatory Compliance Specialist will assess and navigate the existing regulatory landscape for Terumo's medical devices and initiatives, outlining the necessary information and actions to fulfill compliance obligations. The complexity of regulatory strategies will vary based on the scope and diverse international markets. This role...