Quality Assurance Auditor I

Quality Assurance Auditor, GCP - Office-Home-based - Bulgaria, Poland or South Africa

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.

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.
• Read, write and speak fluent English.

To be successful in the role, you will have:

• 3 - 5 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.

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, LifeWorks, 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.

Visit our careers site to read more about the benefits ICON offers.

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