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Última actualización: hace 16 días
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Principal Auditor, Client Relationships QA

Principal Auditor, Client Relationships QA

ICONDenton, TX, US
A tiempo completo
Principal Auditor Quality Assurance.ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and exce...Mostrar másÚltima actualización: hace 16 días
Jr. QA Analyst Trainee

Jr. QA Analyst Trainee

SQA²Denton, TX
A tiempo completo
Recent grads / current college students with : .Software Quality Assurance (Previous QA experience not required; we provide full QA training on the job!). Current QA professionals that are tired of s...Mostrar másÚltima actualización: hace más de 30 días
Principal Auditor, Client Relationships QA

Principal Auditor, Client Relationships QA

ICONDenton, TX, US
Hace 16 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

Principal Auditor Quality Assurance

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Principal Auditor Quality Assurance to join our diverse and dynamic team in Client Relationship Quality Assurance (CRQA). As a Principal Auditor CRQA at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies for the sponsor companies we support while establishing, building and maintaining successful relationships with our sponsor companies' counterparts.

What you will be doing :

  • Relationship management with internal business partners within ICON and with sponsor QA counterparts

Client communications support

  • Client audit support
  • Client inspections support
  • Governance

    • Governance structure development and review of quality data (audits, quality issues, inspections) with sponsor quality counterparts, operations within ICON and at the sponsors

  • ICON Quality & Compliance representation at sponsor and internal partnership meetings
  • Risk and issue management

    • Liaise with ICON Q&C functions who carry out the management of quality activities and data (audits, quality issues and inspections)

  • Reviewing quality data managed by ICON Q&C functional teams and tracked in ICON's Audit Compliance Management System (ACMS), Trackwise Digital, the CRQA Principal Auditor will be responsible for :
  • Quality Risk Mitigation
  • Quality Issue Escalation & Root Cause Analysis
  • Data Analysis & Reporting (Trending, interpretation, analysis)
  • Quality Improvements
  • Consultancy

    • QA Consultancy Support

  • GxP Guidance
  • Inspection Readiness
  • Regulation / Requirements Interpretation
  • Contractual Agreements

    • Your profile :

  • Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
  • Minimum of 7 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a leadership role.
  • In-depth knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
  • Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues.
  • Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.

    • What ICON can offer you :

    Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

    In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

    Our benefits examples include :

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

    • At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

    If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

    Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

    Are you a current ICON Employee? Please click here to apply.