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
As an Operations Quality Specialist at ICON, you will support the development and implementation of initiatives and established processes that support operations in maintaining inspection readiness. This position provides global strategic and tactical leadership within our study teams to achieve overall quality goals while always maintaining inspection readiness.
What You Will Do:
- Support overall quality within assigned clinical trials and submissions
- For assigned clinical trials or assets, is point of contact for operational related quality consultation, escalating to QA as needed
- Provide risk-management, consultation, assessment, and recommendations for escalation for potential quality issues or trends
- Provide training and coaching to promote awareness educating study teams towards quality deliverables
- Support teams in adherence to GCP and procedural documents and processes to ensure quality deliverables
- Work with teams to escalate quality issues with CROs to QA, supporting teams to bring CROs into compliance; and looks for opportunity to collaborate with other members of QuIP to trend across Strategic Partnership(s) to communicate to QA.
- Work with Study Team leadership (and QA, as needed) to identify quality issues and plan of action, including support for creation of deviations and development of effective CAPA and Storyboards
- Support inspection readiness activities with the Study CTM/Sr. CTM, Asset Lead, QA Representative, and QuIP Director or designee
- Plan and lead Study Team inspection readiness support meetings based on QA’s plan and Study Team’s needs
- Support QA in their inspection readiness team meetings and collaborate with QA for information needed and requested for any inspections
- Assists with stakeholder engagement across program to ensure compliance with inspection readiness and preparation activities
- Support teams in preparation, execution, and follow-up of regulatory inspections
- Review critical/major findings with QA Audit reports to propose process improvement
- Provide consult on KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to quality
Your Profile:
- Bachelor’s degree or equivalent with a strong emphasis on science or quality management
- Minimum of 5 years’ experience in a pharmaceutical, bio-pharmaceutical, or Contract
Research Organization company, or equivalent
- Minimum of 3 years’ experience in quality role
- Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience
- Ability to travel
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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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
Skills Required
- BA/BS in Life Sciences or RN
- 2-3 years of clinical research experience
- Understanding of ICH guidelines and GCP
- Knowledge of clinical research and drug development concepts
- Working knowledge of EDC, IVRS and CTMS systems
- Proficient in Microsoft Office
ICON plc Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.
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Healthcare Strength — Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
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Leave & Time Off Breadth — Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
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Retirement Support — Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.
ICON plc Insights
What We Do
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
