Senior Auditor, Quality Assurance

hace 1 semana

Buenos Aires, Argentina ICON A tiempo completo

**JOB: Senior Auditor, Quality Assurance**

**Preferred Locations: EMEA** / Mexico / Argentina**

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

**Responsibilities and Qualifications**:
Manage complex Quality Issues to include supporting Root Cause Analysis, Impact Assessment and appropriate Corrective Action and Preventive Action (CAPA) Plans. Respond to audit findings and support audit responses to assess compliance with corporate policies, industry standards, and applicable regulations.

Level 3 auditor independently conducts the following activities as assigned by Quality & Compliance (Q&C) management:

- Manage Quality Issues
- Lead Quality Issue Investigations
- Supports Operations in Root Cause Analysis and CAPA Plan preparation.
- Support Effectiveness Check development and outcomes.
- Manage CAPAs resulting from Sponsor Audits, Inspections and/ or Internal Audits.
- Assist with the implementation and maintenance of an effective Quality Management System/ Quality Assurance program within the relevant Quality & Compliance (Q&C) team.
- Perform departmental and ICON staff training regarding ICON’s quality system, Q&C tasks and processes, applicable standards, and regulations.
- Mentor new or developing Q&C staff as assigned.
- Support business development activities and Q&C initiatives as needed.
- Read, write and speak fluent English.

**What you will have**:

- 3 - 6 years’ experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/ pharmaceutical / healthcare industry.
- Advanced knowledge of GCP (Good Clinical Practice)
- Excellent organizational skills.
- Excellent knowledge of internal auditing standards.
- Must possess a technical knowledge that is applicable to clinical drug development.
- An undergraduate degree, its international equivalent in the sciences, technology, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required
- Extensive experience in investigator site, vendor, and process audits.
- Must be willing to travel up to 35%
- Excellent knowledge of MS Office (including Microsoft Word, PowerPoint and Excel).
- Experience working in a quality assurance role within an internal audit function (preferred).
- Critical thinker that sees the "big picture" (e.g. overall themes, trends, goals), generates innovative ideas and solutions to problems and makes recommendations in the face of complexity, conflicting pressures and ambiguous circumstances.
- Professional communicator, able to gain and maintain a trusted relationship while delivering difficult messages
- Team worker, able to listen to others but also influence in order to see the wider picture and achieve a vision

**Benefits of Working in ICON**:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best-in-class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

  • Senior Quality Assurance Auditor

    hace 1 día

    Buenos Aires, Buenos Aires C.F., Argentina Mandala Tech A tiempo completo

    Compliance Risk Management:As a Senior Specialist, Quality Assurance Auditor at Mandala Tech, you will play a critical role in identifying and mitigating compliance risks associated with our quality management systems and processes. Your expertise in GVP/GCP auditing and regulatory requirements will enable you to develop effective audit plans and collaborate...

  • Senior Specialist, Quality Assurance Auditor

    hace 1 día

    Buenos Aires, Buenos Aires C.F., Argentina SAP A tiempo completo

    Senior Specialist, Quality Assurance AuditorOrganonDescription of The Position: The Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's...

  • Senior Specialist, Quality Assurance Auditor

    hace 1 día

    Buenos Aires, Buenos Aires C.F., Argentina Mandala Tech A tiempo completo

    Senior Specialist, Quality Assurance AuditorMerckDescription of The Position: The Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's...

  • Senior Auditor, Quality Assurance Expert

    hace 1 día

    Buenos Aires, Buenos Aires C.F., Argentina Mandala Tech A tiempo completo

    Job Overview:Mandala Tech is seeking a skilled Senior Specialist, Quality Assurance Auditor to join our team. As a key member of our quality assurance department, you will play a critical role in ensuring the quality and compliance of our products and services. You will have the opportunity to work closely with our cross-functional teams to drive process...

  • Quality Assurance Specialist, Senior Auditor

    hace 1 día

    Buenos Aires, Buenos Aires C.F., Argentina Mandala Tech A tiempo completo

    About Us:Mandala Tech is a leading provider of innovative solutions in the pharmaceutical industry. Our commitment to quality and customer satisfaction has earned us a reputation as a trusted partner for businesses around the world. We are dedicated to fostering a culture of excellence and continuous improvement, where our employees can grow and develop...

  • Quality Assurance and Compliance Lead

    hace 21 horas

    Buenos Aires, Buenos Aires C.F., Argentina SAP A tiempo completo

    About the RoleThis Senior Specialist, Quality Assurance Auditor is responsible for ensuring the quality and compliance of Organon's operations. The position requires a high level of expertise in quality assurance, auditing, and regulatory compliance.Key ResponsibilitiesConduct audits to evaluate Organon's quality management system.Develop and implement...

  • Senior Auditor, Quality Assurance

    hace 1 día

    Buenos Aires, Buenos Aires C.F., Argentina dk consultores A tiempo completo

    At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives. Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...

  • Senior Quality Assurance Manager

    hace 1 día

    Buenos Aires, Buenos Aires C.F., Argentina Token Metrics Inc A tiempo completo

    We are seeking a Senior Quality Assurance Manager to oversee our Quality Assurance team at Token Metrics Inc. As a Senior Quality Assurance Manager, you will be responsible for overseeing all aspects of software and product testing within the company.Key ResponsibilitiesDeveloping test strategies and drawing up test documents to ensure the highest quality...

  • Auditor Specialist, Quality Assurance Senior

    hace 1 día

    Buenos Aires, Buenos Aires C.F., Argentina Mandala Tech A tiempo completo

    Job Description:As a Senior Specialist, Quality Assurance Auditor at Mandala Tech, you will be responsible for ensuring quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance...

  • Quality Compliance Auditor Expert

    hace 21 horas

    Buenos Aires, Buenos Aires C.F., Argentina SAP A tiempo completo

    Job DescriptionThis Senior Specialist, Quality Assurance Auditor plays a critical role in ensuring the quality and compliance of Organon's operations. The position requires a deep understanding of regulatory requirements and the ability to conduct audits that meet these standards.ResponsibilitiesConduct audits to evaluate Organon's systems, processes, and...

  • Senior Quality Assurance Specialist

    hace 21 horas

    Buenos Aires, Buenos Aires C.F., Argentina SAP A tiempo completo

    Job OverviewThe Senior Specialist, Quality Assurance Auditor, is responsible for ensuring quality and compliance with local and international regulatory requirements. This role involves conducting internal and external audits to evaluate Organon systems, processes, affiliates, vendors, business partners, and investigator sites for compliance with regulatory...

  • Quality Assurance Coordinator

    hace 1 semana

    Buenos Aires, Argentina Givaudan A tiempo completo

    The **Quality Assurance Coordinator**, reporting to the Head of Quality Assurance Americas, based on our Fragrances site, will support the execution of the Quality Assurance, Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) Strategy, in relation to the overall objective of the function to assure the safety, compliance, legality and...

  • Senior Quality Assurance Professional

    hace 4 días

    Buenos Aires, Buenos Aires C.F., Argentina OneSeven Technology (formerly 17 Web Dev) A tiempo completo

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Engineer to join our quality assurance team. As a key member of our team, you will be responsible for assessing software quality through manual and automated testing.You will develop and execute test cases, scripts, plans, and procedures for web/mobile/ai apps. Your role will also involve...

  • Quality Assurance Expert

    hace 12 horas

    Buenos Aires, Buenos Aires C.F., Argentina Meteor A tiempo completo

    About the RoleThe Quality Assurance Lead will be instrumental in building and leading the quality assurance function from the ground up at Meteor Screens.This hands-on leadership role is essential to ensure the company's high standards of quality are met across all software products.As Quality Assurance Lead, you will design and implement quality assurance...

  • Senior Quality Assurance Specialist

    hace 4 días

    Buenos Aires, Buenos Aires C.F., Argentina Tietoevry A tiempo completo

    About the Role:We are seeking a highly skilled Senior Automation QA Engineer to join our team at Tietoevry. As a key member of our quality assurance team, you will be responsible for designing, developing, and implementing comprehensive test automation frameworks to ensure the delivery of high-quality software releases.With a strong background in quality...

  • Software Quality Assurance Specialist

    hace 4 días

    Buenos Aires, Buenos Aires C.F., Argentina OneSeven Technology (formerly 17 Web Dev) A tiempo completo

    Role OverviewWe are looking for a skilled Senior Quality Assurance Engineer to join our quality assurance team. In this role, you will assess software quality through manual and automated testing.Your responsibilities will include developing and executing test cases, scripts, plans, and procedures for web/mobile/ai apps. You will also research and find AI...

  • Senior Quality Assurance Manager

    hace 2 horas

    Buenos Aires, Buenos Aires C.F., Argentina Previously Emigra Argentina S.R.L. A tiempo completo

    Job OverviewWe are seeking a highly skilled Senior Quality Assurance Manager to join our team. As the Technical Lead, you will be responsible for leading multiple policy change implementation projects within the Risk Management Organization.The ideal candidate will have 7+ years of experience in developing software solutions for web, microservices, batch...

  • Staff Auditor ISO 27001

    hace 2 semanas

    Buenos Aires, Argentina Insight Assurance A tiempo completo

    COMPANY PROFILE Insight Assurance is a security and compliance firm trusted by over 1200 organizations for their SOC 2, PCI DSS, ISO 27001, and HIPAA audit needs. Insight Assurance is a licensed CPA firm, PCI Qualified Security Assessor (QSA), and ISO 27001 Certification Body founded by former Big-4 professionals (Former EY) looking to simplify the world of...

  • Senior Quality Assurance Specialist

    hace 1 día

    Buenos Aires, Buenos Aires C.F., Argentina AgileEngine A tiempo completo

    About AgileEngineWe specialize in developing innovative digital display solutions, turning traditional screens into dynamic interfaces for modern businesses. Committed to seamless user experiences and cutting-edge technology, we foster an environment centered on creativity, collaboration, and continuous learning.Job DescriptionThe Quality Assurance Lead will...

  • Senior Quality Assurance Engineer

    hace 2 días

    Buenos Aires, Buenos Aires C.F., Argentina Air Liquide A tiempo completo

    **About the Role:**Senior Quality Assurance Engineer - AQA and TestingThis is an exciting opportunity to join our quality assurance team as a Senior/Lead AQA Engineer. You will be responsible for developing and implementing test strategies, creating automated tests, and maintaining test automation frameworks.**Key Responsibilities:Develop and implement test...