Senior Auditor, Quality Assurance - EDS team (Early Development Services)

Senior Auditor, Quality Assurance - Netherlands, Assen Hybrid: Office/Remote

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 Early Development Services (EDS) division of ICON is a global leader in providing early-phase clinical research (phase I and IIa) and bioanalytical services to the pharmaceutical and biotechnology industries. With a reputation built on excellence, quality and professionalism, we work with leading pharmaceutical and biotechnology companies, performing clinical research and bioanalytical trials on many of the most advanced experimental drugs and biologics in development today. Employees of EDS are enthusiastic and dedicated and work in a dynamic informal organization.

This role is onsite in ICON's office in Assen, Netherlands (32 to 40 hours).

What will you be doing as (Senior) Quality Assurance Auditor?

We are looking for you to join our team onsite in Assen, the Netherlands where you will take responsibility for Bioanalytical Laboratory study audits and parts of the ICON audit program.

•    Perform routine and complex study, vendor and process audits according to GxP regulations, scientific guidelines, client expectations and/or ICON SOPs. May function as a lead auditor on an (international) audit team. Ensure planning, conduct, reporting, responses and FU actions are managed according to internal procedures.
•    Further aspects of this challenging role include the interpretation of regulations and guidance documents governing Bioanalytical studies (GLP, ICH M10, GCP, EMA etc.) and applying this within day-to-day structures for ICON staff and client representatives.
•    You will be additionally responsible for facilitating client audits and regulatory inspections at ICON.

What do we ask of you?

•    Life science degree (secondary vocational education (MBO), Bachelor or University Degree) from an accredited institution.
•    Previous experience working as a GLP Auditor is considered as an asset.
•    Additional experience on any of the following topics is considered a pro: Dataintegrity, CSV.
•    Work experience in a bioanalytical laboratory is considered an additional benefit.
•    Be familiar with techniques such as LCMS, Elisa, Flow cytometry is considered as an additional benefit.
•    Fluency in English.
•    You are a self-motivated, focused individual with excellent communication skills.

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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