Senior Auditor, Quality Assurance - Tech QA team

Sr Auditor, QA - remote - Bulgaria or Poland

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.

Senior Auditor (Technology & CSV)

The role:

We are currently seeking a Senior Auditor Quality Assurance to join our diverse, dynamic and passionate Tech QA team. In this role, 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.

What you will be doing:

• Utilizing a strong knowledge of regulatory expectations and industry knowledge you will provide expert consultancy and compliance advice within ICON for current and emerging technology related topics, such as eClinical Systems and AI.
• Perform a variety of audit activities including internal process audits (with a technology component), technology vendor audits, computerized system and equipment audits.
• Perform Data Integrity Reviews of processes/systems and Validation Assessments of computerized systems.
• Participate as a Technology related Subject Matter Expert during inspections, sponsor audits and in support of Quality Issues.
• Mentor and train junior staff.

Your profile:

• Bachelor's degree in Life Sciences, Pharmacy, IT or related field; advanced degree preferred. 
• Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, healthcare or CRO industry.
• Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues spanning multiple systems and/or business areas.
• Proven auditing experience of computerized systems, processes and vendors used in a clinical development and manufacturing setting.
• In-depth knowledge of data integrity, computerized system validation, delivery/service models, oversight frameworks and emerging trends (e.g. 21 CFR Part 11, Annex 11 & EMA Guidance, Computer Software Assurance, Agile, ITIL, GDPR, Information Security, AI).
• Familiar with regulations and guidance governing clinical trials and drug development (e.g. ICH, FDA, EMA covering GLP, GCP, GVP, GMP, GDP and Medical Devices).
• Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.
• Ability to travel more than 20%. 

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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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