About this role
About the Role Senior Auditor, Quality Assurance at ICON leads audits of clinical trial processes and systems to ensure regulatory compliance, contributes to inspection readiness, and helps strengthen the quality management program. The role involves interpreting regulatory requirements and providing guidance to stakeholders to advance clinical development. What You'll Do
- Leading and conducting comprehensive audits of clinical trial processes, systems, and documentation to ensure compliance with regulatory standards and guidelines.
- Contributing to inspection readiness and participating in health authority inspections as needed.
- Developing and implementing audit plans and strategies to assess the effectiveness of quality management systems.
- Providing expert guidance and practical recommendations to stakeholders regarding GCP and quality assurance best practices.
- Identifying areas for improvement and contributing to the continuous enhancement of QA programs and initiatives. What We're Looking For
- Bachelor's degree in Life Sciences, Pharmacy, or a related field, or equivalent relevant experience.
- Minimum of 5 years of experience in quality assurance, auditing, or inspections within the pharmaceutical, biotechnology, or CRO industry.
- Proven experience with GCPs (Good Clinical Practices), site audits, and clinical quality oversight. (NOT other GxP's)
- Strong understanding of regulatory requirements and quality systems related to clinical research.
- Analytical mindset with excellent problem-solving abilities and attention to detail.
- Effective communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams.
- Advanced English proficiency, fluent in reading, writing, and speaking. Compensation & Benefits
- Competitive salary and a range of benefits focused on well-being and work-life balance.
- Various annual leave entitlements.
- Health insurance offerings and retirement planning options.
- Global Employee Assistance Programme (LifeWorks) with 24-hour access to support.
- Life assurance, flexible country-specific optional benefits, and other perks.