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:

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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.

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