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
Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization, proud to foster an inclusive environment that drives innovation and excellence.
We are currently seeking a Quality Assurance Specialist to join our diverse and dynamic team. This role is responsible for supporting quality compliance across ICON’s clinical programmes, with a particular focus on externally manufactured Clinical Trial Materials (CTM), including Finished Drug Product, clinical packaging, and labeling.
This role is accountable for batch disposition for Clinical Trials Materials manufactured at CMOs.
What You Will Do
- Support and execute quality oversight activities for Clinical Trial Materials manufactured at external CMOs.
- Ensure consistent application of quality compliance by aligning daily activities with applicable cGMP regulations (US, EU, and other regions as required).
- Review batch documentation, supporting data, certificates of analysis, and technical reports for Finished Drug Product, clinical packaging, and labeling.
- Support batch disposition processes in accordance with established quality procedures and regulatory requirements.
- Facilitate and support deviation investigations, change controls, CAPAs, investigations, and nonconformance activities related to clinical manufacturing and external supply.
- Participate in inspection readiness activities and support internal, vendor, and regulatory audits and inspections.
- Identify, assess, and escalate product-related quality and regulatory issues and emerging trends.
- Work closely with Clinical Supply, Regulatory Affairs, Technical Operations, external Qualified Persons (QPs), and other stakeholders involved in external manufacturing and supply.
Your Profile
- Bachelor’s degree in a related field.
- At least 3 years of relevant QA compliance and/or Quality Product Disposition experience in the pharmaceutical or biotech industry.
- Working knowledge of cGMP regulations.
- Experience reviewing manufacturing or clinical documentation.
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 a competitive salary, ICON offers a comprehensive range of benefits designed to support well‑being, work‑life balance, and long‑term career growth. Benefits are competitive within each country and tailored to support you and your family.
Our benefits may include:
Visit our careers site to learn more about the benefits ICON offers.
At ICON, inclusion and belonging are fundamental to our culture and values. We are dedicated to providing an inclusive and accessible environment for all candidates and are committed to maintaining a workplace free from 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 you require a reasonable accommodation due to a medical condition or disability at any stage of the application process, or in order to perform the essential functions of the role, please let us know or submit a request.
Interested in the role, but unsure if you meet all of the requirements? We encourage you to apply—there’s every chance you’re exactly what we’re looking for, whether for this role or other opportunities at ICON.
If you are a current ICON employee, please apply through the internal careers portal.
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