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Clinical Quality Compliance Specialist

ICON Public Limited Corporation

Office Based, Mexico City

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, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.That’s our vision. We’re driven by it. And we need talented people who share it.If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

The role:

Act as an expert advisor on ICH GCP, ICON SOPs/WPs and all stages of study management for assessment of quality compliance processes. Become involved, when required, in other areas of services and staff training and contribute to the review of ICON systems and quality procedures as appropriate.

Responsibilities:

  • Recognize, exemplify and adhere to ICON's values which centres around our commitment to People, Clients and Performance.

  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement, with a focus on streamlining our processes adding value to our business and meeting client needs.

  • Contribute to the investigation and assessment of Sponsor quality compliance events

  • Attend internal and external meetings, assisting in the production of presentation materials, generating meeting minutes

  • Identify potential non-compliance/breaks of quality control steps, as measured through SOP, WP and industry standards

  • Develop Sponsor CAPAs for reported quality events

  • Implement and track corrective and preventative action plans for Sponsor quality events

  • Escalation as appropriate to senior management with proposed solutions

  • Prepare reports of quality trends, as required by management.

  • Provide quality compliance services to other operational departments/vendors, as required

  • Other duties as assigned

What you need?

  • Advanced English level

  • Bachelors Degree

  • 1.5+ years experience in similar roles

Benefits of Working in ICON:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.ICON 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.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 through the form below.

Job posted: 2023-03-09

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