Principal Quality Assurance Professional - Vendor Management

Principal Quality Assurance Professional - Vendor Management - Mexico - Homebased

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.

Our Vendor QA group is a fabulous team of GxP QA professionals who oversee the quality assurance assessment, onboarding, oversight, qualification and tracking of regulated vendors.  Teamwork, can-do spirit and collaboration are the hallmarks of our group.  We have fun, laugh, pull together and get it done.

With hundreds of vendors from all GxP disciplines, there is no shortage of excitement and opportunity from which to learn and grow. Consider bringing your talent to this dynamic group.

What you will be doing

Performing risk assessments for new vendor requests in compliance with regulatory expectations to determine QA qualification requirements for onboarding.

Liaising with auditors (internal & external), sponsors, procurement, operational staff and vendors to develop Audit Scope / Plan and to coordinate qualification, surveillance and for-cause audits of vendors.

Reviewing vendor Audit Reports, Observations along with auditee responses to ensure compliance of vendors and determine qualification status.

Executing Vendor CAPA management (tracking, follow-up, evidence review and closure).

Developing / archiving / maintaining audit documentation e.g. audit scope, audit certificates, ICON official audit records, CAPA documentation.

Assisting with the evaluation, development and issuance of yearly Supplier Audit Schedule and quarterly revisions / updates

Supporting regulatory inspection or sponsor audit requests for vendor qualification evidence.

Contributing to team meetings, respond to regulatory related queries received by Vendor QA and escalate any issues to relevant management for action.

Travel is not expected except in rare or unusual circumstances.

Your profile

• BSc degree mandatory (preferably in a Life Science or similar area).
• At least 5 years of relevant experience in a regulated environment (preferably within QA, risk-assessment, risk management).
• Thorough knowledge of GxP regulations for the conduct of clinical trials (GCP essential; some / all of GLP, GMP, GVP, GDP, Medical Devices, CSV desirable).
• Familiarity with all aspects of vendor management / oversight.
• Excellent planning and organizational skills with the ability to multi-task and prioritize effectively.
• Articulate communication and writing skills.
• Effective and efficient problem solving.
• Ability to own assigned tasks and drive to completion; ability to work independently.
• Excellent or Advanced English level .

#LI-DT2

#LI-Remote

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 :

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