Senior Auditor, Quality Assurance

ICON; New York (NY); Remote; USD 80,000 - 120,000; Full time

Job summary

A leading healthcare intelligence organization is seeking a Senior Auditor for Quality Assurance. This remote role involves ensuring compliance in clinical trials, managing quality issues, and mentoring staff. Join a diverse team committed to innovative treatments and therapies.

Benefits

Annual Leave Entitlements

Health Insurance Options

Retirement Planning

Global Employee Assistance Programme

Life Assurance

Flexible Country-Specific Benefits

Qualifications

• At least 5 years’ experience in a clinical or quality environment.
• Advanced knowledge of GCP (Good Clinical Practice).

Responsibilities

• Manage complex Quality Issues and support CAPA Plans.
• Conduct training on ICON’s quality system and processes.
• Lead regulatory inspections and audits.

Skills

Organizational Skills

Critical Thinking

Professional Communication

Collaboration

Education

Undergraduate Degree in Sciences or Technology

Tools

MS Office

Job description

Senior Auditor, Quality Assurance (Remote Based)

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.

We are currently seeking a Senior Auditor Quality Assurance to join our diverse and dynamic team. As a Senior Auditor Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

Job Location: Bangalore

(Remote Based)

Responsibilities and Qualifications:

• Manage complex Quality Issues, supporting Root Cause Analysis, Impact Assessment, and appropriate Corrective Action and Preventive Action (CAPA) Plans.
• Respond to audit findings and support audit responses to assess compliance with corporate policies, industry standards, and applicable regulations.
• Lead/Support regulatory Inspection hosting.
• Lead/Support Sponsor Audit Hosting.
• Independently conduct activities assigned by Quality & Compliance (Q&C) management.
• Manage Quality Issues and lead Quality Issue Investigations.
• Support Operations in Root Cause Analysis and CAPA Plan preparation.
• Support development and outcomes of Effectiveness Checks.
• Assist with implementing and maintaining an effective Quality Management System/Quality Assurance program within the Q&C team.
• Perform departmental and ICON staff training on ICON’s quality system, Q&C tasks, processes, standards, and regulations.
• Mentor new or developing Q&C staff as assigned.
• Support business development activities and Q&C initiatives as needed.
• Host regulatory inspections of the site/ICON/Sponsor as Lead Host or Co-host.
• Host Sponsor audits of ICON as Lead Host or Co-host.

What you will have:

• At least 5 years’ experience in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/pharmaceutical/healthcare industry.
• Advanced knowledge of GCP (Good Clinical Practice).
• Excellent organizational skills.
• Technical knowledge applicable to clinical drug development.
• An undergraduate degree or equivalent in sciences, technology, auditing, etc., or sufficient auditing experience.
• Excellent knowledge of MS Office (Word, PowerPoint, Excel).
• Critical thinking skills, ability to see the big picture, generate innovative solutions, and recommend actions amid complex situations.
• Professional communication skills to build trusted relationships and deliver difficult messages.
• Ability to influence and collaborate within a team to achieve shared goals.
• Fluent in reading, writing, and speaking English.

What ICON can offer you:

Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options for you and your family
• Retirement planning offerings
• Global Employee Assistance Programme (LifeWorks)
• Life assurance
• Flexible country-specific benefits like childcare vouchers, gym discounts, travel passes, health assessments, etc.

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

At ICON, inclusion & belonging are fundamental. We are committed to providing an accessible, discrimination-free workplace. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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

If you’re interested but unsure if you meet all requirements, we encourage you to apply. You might be exactly what we’re looking for, whether for this or other roles at ICON.

Current ICON employees can apply here.