Job Summary:

Under the leadership of the Director of Development Operations Quality (DOQ) or designee, this position is responsible for DOQ collaborations with Global Monitoring and Clinical Study Support and Regional Clinical Operations. This position leads collaborations at country and regional level, as assigned. This position leads consultation on continuous improvement of established processes and procedures. This position provides global strategic and tactical leadership within our study teams to achieve overall quality goals while always maintaining inspection readiness. This position may sit across the entire global portfolio or a particular asset(s). These activities will be in collaboration with Quality Assurance (QA) and the Quality Lead/Specialist, as needed. With QA leading, this position supports study teams during regulatory inspections.

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 requirementsReview 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 protocolsSupport overall quality within assigned clinical trials and submissionsFor assigned clinical trials or assets, is point of contact for operational related quality consultation, escalating to QA as neededProvide risk-management, consultation, assessment, and recommendations for escalation for potential quality issues or trendsProvide training and coaching to promote awareness educating study teams towards quality deliverablesSupport teams in adherence to GCP and procedural documents and processes to ensure quality deliverablesWork 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 StoryboardsSupport inspection readiness activities with the Study CTM/Sr. CTM, Asset Lead, QA Representative, and DOQ Director or designeePlan and lead Study Team inspection readiness support meetings based on QA’s plan and Study Team’s needsSupport QA in their inspection readiness team meetings and collaborate with QA for information needed and requested for any inspectionsAssists with stakeholder engagement across program to ensure compliance with inspection readiness and preparation activitiesSupport teams in preparation, execution, and follow-up of regulatory inspectionsReview critical/major findings with QA Audit reports to propose process improvementProvide 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 TeamsDevelop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysisProvide training or awareness for new or established processes or guidance provided by DOQCollaborate in developing and presenting DOQ content for distribution within the organizationAuthor relevant content for the DOQ SharePoint siteAct as lead on specified DOQ workstreams or assigned DOQ initiativesIn collaboration with the Operations Quality Lead/Specialist, provide consultation and support for ad hoc requests that are sent to DOQConsult, develop, or identify opportunities for continuous improvement projectsDevelop, review, and analyze KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to quality within Development OperationsStay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trialsFacilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensusDevelop matrix relationships to involve process experts and conduct improvement activitiesCollaborate with DOQ Leadership to ensure integration, alignment, and consistent messaging across the organizationPromote 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 proceduresExperience 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 challengesExperience in risk and issue management and in assessment of non-compliance against relevant study documents, procedures, ICH GCP, and regulatory requirementsAdept at identifying and investigating issues, identifying root cause, and able to facilitate cross-functional solutions with stakeholdersExperience in developing or contributing to processes and/or SOPs and/or WIsAbility to lead and execute continuous improvementExperience in inspection preparation, participation, and follow-upExperience with audits and inspections of sponsor/CRO/site/vendorExposure to all phases of clinical trialsBroad knowledge of Clinical Operations with prior regulatory knowledge desired

Minimum Requirements:

Bachelor’s degree preferred or experience in lieu of a degreeMinimum of 5 years’ experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalentMinimum of 5 years’ experience in quality roleMust have working knowledge of ICH GCP and other relevant regulatory/health authority experience Ability to travel

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $103,900.00 - $173,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.