# Senior Auditor, Quality Assurance (GMP)

**Company**: ICON
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Netherlands-Groningen-GRQP/Senior-Auditor--Quality-Assurance_JR153802?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_ed021bbb-ecf

## Description

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a Senior Auditor, Quality Assurance, you will take a lead role in delivering quality assurance activities that ensure regulatory compliance and operational excellence across manufacturing and clinical development functions.

**Responsibilities:**

- Planning, leading, and conducting GMP-focused audits of processes, systems, vendors, facilities, and documentation.

- Performing study-specific quality assurance activities to support clinical development programs.

- Evaluating compliance with global regulatory requirements, including GMP, ICH guidelines, and applicable health authority regulations.

- Identifying quality risks and partnering with cross-functional teams to drive effective corrective and preventive actions.

- Providing expert guidance to internal stakeholders on quality systems, compliance expectations, and audit readiness.

- Supporting the continuous improvement of ICON's Quality Management System and quality assurance processes.

- Contributing to regulatory inspection readiness activities and follow-up actions as required.

**Requirements:**

- Bachelor's degree in a scientific or related discipline.

- Significant Quality Assurance experience within the pharmaceutical, biotechnology, or CRO industry.

- Strong understanding of clinical research processes and the regulatory framework governing clinical development.

- Demonstrable experience conducting and leading GMP audits.

- Thorough knowledge of global GMP requirements and quality management systems.

- Strong analytical, problem-solving, and risk assessment skills.

- Excellent communication skills with the ability to influence and engage stakeholders at all levels.

- Willingness to travel internationally as required (approximately 35%).

**Preferred Experience:**

- Formal auditor qualifications or additional training/certification in auditing.

- Experience supporting both manufacturing operations and clinical research environments.

- Exposure to global regulatory inspections and supplier/vendor auditing programs.

**Rewards & Benefits:**

- Competitive base salary and performance-related incentives

- Health and wellbeing programmes including medical, dental, and vision coverage where applicable

- Retirement and pension plans

- Life assurance and disability coverage

- Employee assistance programmes and wellbeing resources

- Learning and development opportunities through structured training and career pathways

## Skills

### Required
- GMP
- Quality Assurance
- Clinical Research
- Regulatory Compliance
- Audit

### Nice to have
- Formal auditor qualifications
- Manufacturing Operations
- Global Regulatory Inspections

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