Sr. Global Operations Quality Manager
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.
Quality and GCP Oversight
Provide quality consultation within assigned scope, escalating complex or enterprise- impacting issues to the Senior Global Quality Manager and/or Global Head - GCP Excellence, as appropriate
Lead issue assessments, root cause evaluation, and recommendations for QA escalation
Lead cross-study quality initiatives to define best practices, enhance quality maturity, and strengthen proactive risk identification
Support teams in interpreting and applying ICH GCP, regulatory expectations, procedural documents, and governance frameworks
Provide direction for deviation management, CAPA development, and quality-related storyboards
Promote a culture of quality, continuous improvement, and operational excellence that engages colleagues in positive dialogue consulting and supporting in all we do
Data Governance, Lessons Learned & Continuous Improvement
Develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, as assigned
Contribute to the enhancement or creation of SOPs, WIs, guidance documents, and process optimization initiatives.
May drive continuous improvement projects aimed at strengthening quality culture, efficiency, and inspection readiness maturity
Provide training or awareness for new or established processes or guidance provided by QuIP
Collaborate in developing and presenting QuIP content for distribution within the organization
Author relevant content for the QuIP SharePoint sites
May act as lead on specified QuIP workstreams or assigned QuIP initiatives
Provide consultation and support for ad hoc requests that are sent to QuIP Consult, develop, or identify opportunities for continuous improvement projects
Stay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trials
Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensus
Study Team Support Activities
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
Work with teams to escalate quality issues with CROs to QA, support teams to bring CROs into compliance; and look for opportunities 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, preparation and conduct activities with the Study CTM/Sr. CTM, Asset Lead, QA Representative, and QuIP Leadership or designee as requested by the QuIP Inspection Excellence team.
Review critical/major findings with QA Audit reports to propose process improvement
Provide consultation on KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to quality
Skills/Experience
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 causes, and being able to facilitate cross-functional solutions with stakeholders
Experience in developing or contributing to processes and/or SOPs and/or WIs
Ability to lead and execute continuous improvement
Experience in inspection preparation, participation, and follow-up
Experience with audits and inspections of sponsor/CRO/site/vendor
Strong verbal and written communication skills with ability to effectively communicate with a broad range of stakeholders at all levels to build strong, positive relationships under challenging and evolving landscapes
Ability to interact with key stakeholders and create and present complex information effectively to promote excellence in quality
Acute attention to details with ability to extrapolate facts and communicate succinctly and confidentially
Strong cooperative team player with the ability to be flexible and adapt to a changing environment
Used to working in a multidisciplinary setting with a strong customer-orientation
Ability to effectively manage multiple priorities simultaneously
Strong planning, prioritization, and organizational skills, and able to work independently or within a group
Minimum Requirements
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
5+ years’ experience in quality roles
Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience
Demonstrated experience with audits, inspections, and complex escalation management
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.
Are you a current ICON Employee? Please click here to apply
