Operations Quality Specialist
Operations Quality Specialist
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
Apply To This Job
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
Apply To This Job