Auditor, Quality Assurance

• Mexico City, Sofia, Dublin, Warsaw, Bucharest

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.

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:

Utilising 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 computerised 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 computerised systems, processes and vendors used in a clinical development and manufacturing setting.

In-depth knowledge of data integrity, computerised 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 travelmore than20%.

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.

A better career. A better world. A better you.

Our people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader . See all locations Read more

A better career. A better world. A better you.

Our people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader . See all locations Read more

A better career. A better world. A better you.

Our people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader . See all locations Read more

A better career. A better world. A better you.

Our people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader . See all locations Read more

A better career. A better world. A better you.

Our people are our greatest strength , are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers , deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader . See all locations Read more Things to consider heading into 2023 if you're thinking about moving jobs. Life sciences are undeniably an exciting area to start and pursue a career in. #J-18808-Ljbffr