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

ICON; New York (NY); Hybrid; USD 60,000 - 100,000; Full time

Job summary

Join an innovative firm as a Senior Auditor in Quality Assurance, where you will play a crucial role in ensuring compliance with GxP regulations in bioanalytical studies. This dynamic position offers the chance to work alongside leading professionals in the healthcare sector, contributing to the development of cutting-edge therapies. With a focus on quality and excellence, you'll have the opportunity to lead audits, interpret regulatory guidelines, and facilitate client inspections. Enjoy a supportive and inclusive work environment that values your contributions and promotes work-life balance.

Benefits

Health Insurance Options

Retirement Planning Options

Global Employee Assistance Programme

Flexible Benefits

Various Annual Leave Entitlements

Qualifications

• Life science degree from an accredited institution.
• Previous experience as a GLP Auditor is an asset.
• Experience in a bioanalytical laboratory is beneficial.

Responsibilities

• Perform routine and complex audits according to GxP regulations.
• Interpret regulations governing Bioanalytical studies.
• Facilitate client audits and regulatory inspections.

Skills

GLP Auditing

Data Integrity

Communication Skills

Bioanalytical Laboratory Experience

Fluency in English

Education

Life Science Degree

Tools

LCMS

ELISA

Flow Cytometry

Job description

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.

1. 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 follow-up actions are managed according to internal procedures.
2. Interpret regulations and guidance documents governing Bioanalytical studies (GLP, ICH M10, GCP, EMA, etc.) and apply this within day-to-day structures for ICON staff and client representatives.
3. Facilitate 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 an asset.
• Additional experience in Data Integrity, CSV is a plus.
• Work experience in a bioanalytical laboratory is beneficial.
• Familiarity with techniques such as LCMS, ELISA, Flow cytometry is advantageous.
• Fluency in English.
• You are a self-motivated, focused individual with excellent communication skills.

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 a competitive salary, ICON offers a range of benefits focused on well-being and work-life balance, including:

• Various annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme (LifeWorks)
• Life assurance
• Flexible, country-specific benefits such as childcare vouchers, bike schemes, gym memberships, travel passes, and health assessments

Visit our careers site to learn more about ICON’s benefits.

ICON values inclusion & belonging, providing an accessible environment for all candidates. We are committed to equal opportunity employment and encourage applications from all qualified candidates.

If you need a reasonable accommodation during the application process or to perform the job functions, please let us know or submit a request here.

Interested but unsure if you meet all requirements? We encourage you to apply—your skills may be exactly what we're looking for.

Current ICON employee? Please click here to apply.