Senior Auditor, Quality Assurance - GCP

ICON; New York (NY); Remote; USD 80,000 - 110,000; Full time

Job summary

ICON is seeking a Senior Auditor for its global Clinical Quality Assurance team. This office-based or remote role emphasizes auditing responsibilities, business partnering, and mentoring within a healthcare research context. The ideal candidate will possess solid audit experience, GCP knowledge, and excellent communication skills, contributing to the organization's mission in clinical development.

Benefits

Competitive salary

Health insurance offerings

Retirement planning

Global Employee Assistance Programme

Flexible optional benefits

Qualifications

• Solid experience in clinical audits and understanding of related regulations.
• Fluent in English with excellent written and verbal communication skills.
• Able to operate under moderate supervision.

Responsibilities

• Planning and conducting clinical internal audits, reporting results.
• Supporting management in business partnering with service lines.
• Training and mentoring less experienced QA auditors.

Skills

Clinical Audit experience

GCP knowledge

Excellent communication skills

Organizational skills

Interpersonal skills

Job description

Senior Auditor, Quality Assurance - Office-based or Remote - Bulgaria, Poland, South Africa

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 seeking a Senior Auditor to join our global Clinical Quality Assurance team in ICON Quality & Compliance.

Our ICON Clinical QA (CQA) team is seeking a Senior Auditor candidate that is very keen on joining a passionate and highly inclusive team of QA professionals. Not only will you bring your own experience and knowledge to us, our Team will also keenly share its passion, expertise and knowledge with you! You will have lots of opportunities to partner with other highly skilled ICON professionals through an interesting variety of activities. From the moment you start your new position with us, our Team will support and encourage you to grow beyond it.

With excellent knowledge of GCP and a solid experience in conducting clinical QA audits, as a Senior Auditor in our Clinical Quality Assurance team you will represent ICON Quality & Compliance in partnering with diverse service lines and operational departments, which are primarily involved in service provision for Phase II-IV and Late Phase studies / activities.

Your key responsibilities and tasks will include the following:

Auditing responsibilities:

• Assisting CQA management with and/or oversee the assigned internal audit schedule

• Planning and conducting regular clinical internal audits as assigned (project, site, process audits) as well as assigned contracted audits, for cause audits, vendor and sub-contractor audits.

• Reporting the results of the audit and any relevant findings and track them into the ICON systems as requested.

• Reviewing audit responses by the auditees. Follow up all outstanding replies and escalate issues to the relevant management for action.

• Training, mentoring and developing less experienced QA auditors

Business Partnering responsibilities:

• Provide support to CQA management in business partnering with assigned service line/departments (e.g. through regular meetings and related preparation/ follow-up of actions)

• Partner with relevant business service lines / departments in facilitating compliance with Quality Management System / Quality Assurance program (e.g. CAPA support).

• This also may include liaising with clients in support of contracted audits or other quality / compliance related matters.

• Support SOP/Process documentation review as assigned by management

This role would require travel primarily across the EMEA region (up to 35%), on occasion this may increase depending on business needs.

Experience and skills for the role:

• Solid Clinical Audit experience

• Excellent knowledge of GCP and related clinical trial regulations

• Able to operate under moderate supervision and direction

• Excellent verbal and written communication skills and interpersonal skills, with fluent written and spoken English language skills

• Understand key business drivers; uses this understanding to accomplish own work

• Excellent organizational skills

• Excellent interpersonal 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