Senior Auditor, Quality Assurance

Senior Auditor, Quality Assurance (GCP)

Homeworker or Hybrid – Mexico

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 opportunity:

Working in the GRC Compliance team managing quality issues, including supporting operations in the Root Cause Analysis (RCA) and CAPA plan preparation. Other duties include managing Serious Breach Assessments and leading initiatives as needed.

Key responsibilities will include:

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.

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.

To be successful in the role, 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
• Read, write and speak fluent English.

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