Senior Auditor, Quality Assurance

QA Auditor 2 - Bulgaria

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.

Role: Senior Clinical Auditor (GCP)

Location: Poland or Bulgaria (up to 35%  travel)

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

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

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and 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 through the form below.

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.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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