GCP Quality Manager
GCP Quality Manager
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Job Description
Job Summary
Under the leadership of the Director of Development Operations Quality (DOQ) or designee this position supports the Operations Quality Lead for DOQ collaborations with Quality Assurance. 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. This position may sit across the entire global portfolio or a particular asset(s). These activities will be in collaboration with Quality Assurance (QA) the Operations Quality Lead and the Operations Quality Manager as needed. With QA leading this position supports study teams during regulatory inspections.
Summary of Job Responsibilities
Under the leadership of the Operations Quality Lead supports or may lead inspection readiness initiatives
Creates process and tools to achieve inspection readiness within Development Operations
With DOQ leadership helps to facilitate the growth of opportunities for collaboration with QA collaborating with the Operations Quality Lead and the Operations Quality Manager
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 riskmanagement 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
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 QAs plan and Study Teams 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 and followup 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
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 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 and the Operations Quality Manager 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 crossfunctional 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 noncompliance against relevant study documents procedures ICH GCP and regulatory requirements
Adept at identifying and investigating issues identifying root cause and able to facilitate crossfunctional 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 followup
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 customerorientation
Ability to effectively manage multiple priorities simultaneously
Good planning prioritization and organizational skills and able to work independently or within a group
Minimum Requirements
Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience
Bachelors degree or equivalent with a strong emphasis on science or quality management
Minimum of 5 years experience in a pharmaceutical biopharmaceutical or Contract Research Organization company or equivalent
Minimum of 3 years experience in quality role
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
Required Experience:
Manager
Employment Type
Full-Time
