Principal Auditor, Quality Assurance

Principal Auditor, Quality Assurance Cardiac Imaging- East Coast USA- Remote

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 Principal Auditor Quality Assurance to join our diverse, dynamic and passionate Q&C 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 Imaging and Cardiac services related topics.

• Act as the Q&C Business Partner for the ICON Medical Imaging & Cardiac Safety Solutions (IMC) group.

• Provide support for Imaging & Cardiac related external client relationships.

• Development of the IMC annual internal audit schedule as well as support those audit activities as needed.

• Participate during inspections, sponsor audits and in support of Quality Issues of IMC as needed.

• 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.\

• In-depth knowledge of Imaging and/or Cardiac services related to clinical trials

• Familiar with regulations and guidance governing clinical trials and drug development (e.g. ICH, FDA, GDPR, EMA covering GCP, GDP).

• Audit experience of Imaging & Cardiac, processes, computerized systems and/or vendors and advantage.

• Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.

• Ability to travel up to 10%. 

• Must reside in the EAST COAST, US

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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.

Salary range: $91,336.00-$114,170.00

Bonus, Com, Stock, Benefits & Disclaimer verbiage:
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.

Are you a current ICON Employee? Please click here to apply