Sr. Global Operations Quality Manager

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

Role Specific Responsibilities  

• Is point of contact for assigned regional quality and compliance questions, working with QA to ensure alignment and consistent messaging based on GCP and regulatory requirements

• Review or consult in the development or revision of SOPs/WIs (global, regional, local)

• With DOQ leadership, is responsible to facilitate the growth of opportunities for collaboration with Global Monitoring and Clinical Study Support and Regional Clinical Operations, collaborating with the Quality Lead/Specialist as needed

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, supporting teams to bring CROs into compliance; and looks for opportunity to collaborate with other members of DOQ 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 DOQ 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

General Responsibilities

• Develop and maintain guidance and process to facilitate DOQ support of Study Teams

• 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 provided by DOQ

• Collaborate in developing and presenting DOQ content for distribution within the organization

• Author relevant content for the DOQ SharePoint site

• Act as lead on specified DOQ workstreams or assigned DOQ initiatives

• In collaboration with the Operations Quality Lead/Specialist, provide consultation and support for ad hoc requests that are sent to DOQ

• Consult, develop, or identify opportunities for continuous improvement projects

• Develop, review, and analyze KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to quality within Development Operations

• 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

• Develop matrix relationships to involve process experts and conduct improvement activities

• Collaborate with DOQ Leadership to ensure integration, alignment, and consistent messaging across the organization

• Promote a culture of quality, continuous improvement, and operational excellence that engages colleagues in positive dialogue consulting and supporting in all we do

Skills/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

• 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

• Exposure to all phases of clinical trials

• Broad knowledge of Clinical Operations with prior regulatory knowledge desired

• Demonstrated leadership, critical thinking skills, and ability to influence teams driving them to shared consensus

• 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

• Good 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

• Minimum of 5 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:

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.

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