Senior Quality Assurance Auditor

hace 2 semanas


Xico, México Icon Plc A tiempo completo

At Icon Plc, we're driven by a shared vision to advance and improve patients' lives. Our diverse teams enable us to deliver excellence to our clients and patients at every touch-point.

We're looking for a talented Senior Auditor Quality Assurance to join our dynamic and supportive environment. In this role, you will play a pivotal part in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

  • Utilizing a strong knowledge of regulatory expectations and industry knowledge, provide expert consultancy and compliance advice within Icon Plc for current and emerging technology related topics, such as eClinical Systems and AI.
  • Perform a variety of audit activities, including internal process audits with a technology component, technology vendor audits, computerized system and equipment audits.
  • Conduct Data Integrity Reviews of processes/systems and Validation Assessments of computerized systems.
  • Participate as a Technology related Subject Matter Expert during inspections, sponsor audits, and in support of Quality Issues.
  • Mentor and train junior staff.

**Requirements:**

  • Bachelor's degree in Life Sciences, Pharmacy, IT, or related field; advanced degree preferred.
  • Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, healthcare, or CRO industry.
  • Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues spanning multiple systems and/or business areas.
  • Proven auditing experience of computerized systems, processes, and vendors used in a clinical development and manufacturing setting.
  • In-depth knowledge of data integrity, computerized system validation, delivery/service models, oversight frameworks, and emerging trends.
  • Familiar with regulations and guidance governing clinical trials and drug development.
  • Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.
  • Ability to travel more than 20%.


  • Xico, México Icon A tiempo completo

    Job Title: Senior Auditor, Quality AssuranceAt ICON, we're committed to advancing and improving patients' lives through our work in clinical research. As a Senior Auditor, Quality Assurance, you'll play a pivotal role in ensuring the quality and compliance of our clinical trials, interpreting regulatory requirements, and contributing to the advancement of...


  • Xico, México Novo Nordisk A tiempo completo

    We are seeking a Senior Quality Assurance Specialist to join our team at Novo Nordisk. As a key member of our quality assurance team, you will be responsible for ensuring the quality of our products and processes.Key responsibilities include:Developing and implementing quality assurance strategiesConducting audits and assessments to ensure compliance with...


  • Xico, México Organon A tiempo completo

    **Job Summary:**We are seeking a Senior Specialist, Quality Assurance Auditor to join our team at Organon. As a key member of our Quality Assurance Department, you will be responsible for ensuring quality and compliance with local and international regulatory requirements by conducting internal and external audits.Key Responsibilities:Evaluate Organon...


  • Xico, México Syneos - Clinical And Corporate - Prod A tiempo completo

    At Syneos Health, we're accelerating customer success by translating unique clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model brings the customer and the patient to the center of everything we do. We're seeking a Senior Quality Assurance Manager to support our Quality Issue Management initiatives.The Senior...


  • Xico, México Ntt Data A tiempo completo

    Job SummaryWe are seeking a Senior Quality Assurance Engineer to lead our QA team in ensuring the quality of our software products. The ideal candidate will have a strong background in software testing and quality assurance, with experience in leading teams and implementing quality assurance processes.Key ResponsibilitiesLead the development and...


  • Xico, México Labor Hermann A tiempo completo

    About the PositionWe are seeking a skilled Senior Quality Assurance Engineer to join our team at Labor Hermann. As a key member of our remote team, you will be responsible for taking ownership of our large automation test suite and collaborating with developers, Quality Assurance Engineers, and Product Managers on a daily basis.Key ResponsibilitiesDevelop...


  • Xico, México Oilandgas.Org A tiempo completo

    Job Title: Manufacturing Quality Assurance Senior EngineerAt Oilandgas.Org, we are seeking a highly skilled Manufacturing Quality Assurance Senior Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring that our manufacturing processes meet the highest standards of quality and customer satisfaction.Key...


  • Xico, México Capgemini A tiempo completo

    **Job Summary**We are seeking a skilled Senior Quality Assurance Specialist to join our team at Capgemini. As a key member of our Quality Assurance team, you will be responsible for ensuring the highest quality of our software solutions.**Key Responsibilities**Perform functional Integration SIT End to End Testing along with Regression testingDevelop and...


  • Xico, México Novartis A tiempo completo

    Job SummaryWe are seeking a highly skilled and experienced professional to lead our global quality assurance and regulatory compliance efforts. As a Senior Quality Assurance Specialist, you will be responsible for ensuring that our company's products and processes meet the highest standards of quality and regulatory compliance.Key ResponsibilitiesDevelop and...

  • Quality Assurance Auditor

    hace 2 semanas


    Xico, México Icon A tiempo completo

    At ICON, we're committed to advancing clinical research and providing outsourced services to pharmaceutical, biotechnology, medical device, and government organizations.As a Quality Assurance Auditor, you'll play a critical role in ensuring the quality of our services and products. Your responsibilities will include: Leading investigations and root cause...


  • Xico, México Quality Enterprises Usa A tiempo completo

    Quality Control and Assurance SpecialistWe are seeking a highly skilled Quality Control and Assurance Specialist to join our team at Quality Enterprises Usa. As a key member of our quality assurance team, you will be responsible for ensuring that our construction projects meet the highest standards of quality and safety.Key Responsibilities:Conduct quality...


  • Xico, México Schneider Electric Gruppe A tiempo completo

    Job DescriptionJob Title: Manufacturing Quality Assurance Senior EngineerJob Summary: We are seeking a highly skilled Manufacturing Quality Assurance Senior Engineer to join our team at Schneider Electric Gruppe. As a key member of our quality assurance team, you will be responsible for ensuring that our products meet the highest standards of quality and...


  • Xico, México Ntt Data A tiempo completo

    **Job Title:** Senior Quality Assurance Specialist**Job Summary:** We are seeking a skilled Senior Quality Assurance Specialist to join our team at NTT DATA Services. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality of our technical solutions.**Key Responsibilities:**• Work closely with customers,...


  • Xico, México Hsbc A tiempo completo

    - Job DescriptionHsbc is currently seeking an experienced professional to fill the role of Senior Quality Assurance Specialist. This position is responsible for ensuring that cases are audited in accordance with Independent Quality Function procedures and respective line of business procedures.- ResponsibilitiesBe informed of all procedural changes and...


  • Xico, México Global Payments (Beamery) A tiempo completo

    **Job Summary**:We are seeking a highly skilled Senior Quality Assurance Manager to lead our software quality assurance functions. The ideal candidate will have a strong background in quality engineering and experience in managing teams to ensure high-quality releases.**Key Responsibilities**:• Develop and implement quality standards for company...


  • Xico, México Wipro Technologies A tiempo completo

    We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Wipro Technologies. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality of our products and services.Key Responsibilities:Design and implement effective testing strategies to ensure the quality of our products and...


  • Xico, México Cognizant A tiempo completo

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Cognizant. The ideal candidate will have a strong background in software testing and quality assurance, with experience in leading test teams and developing test strategies.Key ResponsibilitiesDevelop and execute test plans and strategies to ensure high-quality...


  • Xico, México Schneider Electric Norge As A tiempo completo

    Job DescriptionAs a Manufacturing Quality Assurance Senior Engineer at Schneider Electric Norge As, you will play a crucial role in ensuring the quality of our products and services. Your primary responsibility will be to lead the quality assurance team and implement continuous improvement initiatives to drive excellence in manufacturing.Main...


  • Xico, México Motorsport-Total Gmbh A tiempo completo

    As a key member of our team at Motorsport-Total GmbH, the Senior Quality Assurance Manager will be responsible for ensuring compliance with safety, ergonomics, and environmental regulations and standards.They will actively participate in environmental/safety management reviews and notify changes in legal requirements.The Quality Systems Specialist will...


  • Xico, México Capgemini A tiempo completo

    Job Summary:We are seeking a highly skilled Senior Software Quality Assurance Engineer to join our team at Capgemini. This is a challenging role that requires a strong background in software quality assurance, with a focus on ensuring the delivery of high-quality software solutions.Key Responsibilities:Manage software quality assurance efforts, ensuring...