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 a Operations Quality Specialist at ICON, you will ensure the highest standards of quality and compliance in our drug development processes.
What You Will Do:
This position supports 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
Key responsibilities include:
Creates process and tools to achieve inspection readiness within Development Operations
Under the leadership of the Operations Quality Lead, develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysis
Provide training or awareness for new or established processes or guidance
Become thoroughly familiar with assigned compounds and protocols
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
Your Profile:
You will have a strong foundation in quality assurance and compliance, with the experience to work independently and guide others.
Required qualifications and experience:
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
Working knowledge of Quality Management methods, systems, and relevant procedures
Experience in providing quality management within Study Teams in the conduct and management of large and complex multinational clinical trials
Experience in managing complex and sensitive operational challenges
Experience in risk and issue management and in assessment of non-compliance against relevant study documents, procedures, ICH GCP, and regulatory requirements
Adept at identifying and investigating issues, identifying root cause, and able to facilitate cross-functional solutions with stakeholders
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 a Operations Quality Specialist at ICON, you will ensure the highest standards of quality and compliance in our drug development processes.
What You Will Do:
This position supports 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
Key responsibilities include:
Creates process and tools to achieve inspection readiness within Development Operations
Under the leadership of the Operations Quality Lead, develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysis
Provide training or awareness for new or established processes or guidance
Become thoroughly familiar with assigned compounds and protocols
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
Your Profile:
You will have a strong foundation in quality assurance and compliance, with the experience to work independently and guide others.
Required qualifications and experience:
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
Working knowledge of Quality Management methods, systems, and relevant procedures
Experience in providing quality management within Study Teams in the conduct and management of large and complex multinational clinical trials
Experience in managing complex and sensitive operational challenges
Experience in risk and issue management and in assessment of non-compliance against relevant study documents, procedures, ICH GCP, and regulatory requirements
Adept at identifying and investigating issues, identifying root cause, and able to facilitate cross-functional solutions with stakeholders
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